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DIA's Content Currents provides you with new and important global regulatory developments and their impact on pharmaceutical, biotechnology, and medical product development.

EDITION PUBLISHED: April 18, 2014

SECTION 1 FDA GUIDANCES & MAPPS

Center for Drug Evaluation and Research (CDER) List of Guidance Documents

CDER Guidances New/Revised/Withdrawn through March 31 2014

New: The links above lead to the List of Guidance Documents (CDER) updated on April 15, 2014, and to CDER Guidances that are new, revised, or withdrawn for the first calendar quarter of 2014.

Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2014 (PDF - 31KB)

CDRH FY 2014 Proposed Guidance Development

On April 17, 2014, FDA issued an Emergency Use Authorization (EUA) for an in vitro diagnostic device for the detection of the novel influenza A (H7N9) virus.  The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the April 19, 2013, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves the novel influenza A (H7N9) virus. (Section 564 of the FD&C Act (21U.S.C. 360bbb–3) as amended by the Project BioShield Act of 2004 (Pub. L.108–276) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113–5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations.) [Federal Register]

On April 17, 2014, FDA announced the availability of a draft guidance entitled ‘‘Live Case Presentations During Investigational Device Exemption Clinical Trials; Draft Guidance for Institutional Review Boards, Industry, Investigators, and Food and Drug Administration Staff.’’ This guidance is intended, in part, to improve the quality of information submitted by sponsors in an IDE application or supplement to an IDE application and to ensure consistency in the review of those submissions. This draft guidance is intended to clarify FDA’s regulations and policies regarding live case presentations using unapproved or uncleared investigational devices in the United States. Comments should be submitted by July 16, 2014, to assure consideration before FDA begins work on the final version of the guidance.  [Federal Register]

On April 14, 2014, FDA announced that a proposed collection of information has been submitted to OMB relating to the Adverse Event Program for Medical Devices (Medical Product Safety Network).   FDA is seeking OMB clearance to continue to use electronic data collection to obtain the information on Form FDA 3500A (approved under OMB control number 0910–0291) related to medical devices and tissue products from the user facilities participating in MedSun, to obtain a demographic profile of the facilities, and for additional questions which will permit FDA to better understand the cause of reported adverse events. Participation in the program is voluntary and currently includes 250 facilities. In addition to collecting data on the electronic adverse event report form, MedSun collects additional information from participating sites about reported problems emerging from the MedSun hospitals. This data collection is also voluntary and is collected on the same Web site as the report information.  Comments may be submitted for consideration by May 14. 2014. [Federal Register]

SECTION 2 FDA NOTES & RELATED NEWS

Hamburg: Focus on Chronic Illness Drugs Needed

Speaking at the PhRMA's annual conference in Washington, DC, Dr. Margaret Hamburg said the FDA needs to re-examine the way it reviews novel drugs that treat chronic conditions to get them to market faster.  She told drug executives that her agency can use lessons learned from reviewing rare disease drugs to help foster innovation in products that treat chronic conditions.

Those lessons include having shorter, smaller, more efficient clinical trials according to Hamburg. The FDA has been successful in recent years with using one of the now small handful of accelerated approval pathways for rare diseases, or for conditions with unmet clinical needs. Those pathways rely on surrogate endpoints or a single clinical trial, and are intended to be easier and take less time.

About half of all drug approvals in recent years have come through one of the FDA's accelerated approval pathways, she said. And with chronic illness becoming so prevalent in the U.S. today, the FDA is looking at taking a similar position with drugs that treat chronic conditions.

Rep. Fred Upton (R-Mich.), who chairs the House Energy and Commerce Committee -- which oversees the FDA -- told the same PhRMA crowd just after Hamburg spoke Thursday that he is launching a full-scale review of the way the FDA regulates the discovery, development, and delivery of drugs.

The goal is to help speed the development and approval of new drugs. Legislation would come early next year, Upton said. (MedPage Today)

New Safety Measures Announced for Extended-release and Long-acting Opioids
FDA approved class-wide labeling changes for all extended-release and long-acting (ER/LA) opioid analgesics announced on September 10, 2013, and responded to two petitions regarding labeling for neonatal opioid withdrawal syndrome (NOWS).  In its response to the petition of the National Advocates for Pregnant Women, FDA explained and documented its rationale for including labeling language intended to raise awareness of the potential impact of long term opioid use during pregnancy on the neonate as well as the need to be prepared for immediate recognition and treatment of NOWS should it occur in the neonate. More at link above. (FDA.gov)

FDA Works with China to Ensure Medical Product Safety

Christopher Hickey, PhD, FDA’s country director for the People’s Republic of China, blogged this week in FDA Voice about his testimony before the US-China Economic and Security Review Commission on April 3.  The Commission is an advisory panel created by Congress, on FDA’s work to ensure the safety and quality of medical products produced in China and imported into the US.

With approximately 40 percent of finished drugs in the United States come from overseas, as well as more than 50 percent of all medical devices, and about 80 percent of the manufacturers of active pharmaceutical ingredients located outside the US, rapid globalization has presented challenges to regulators who oversee the safety and quality of medical products. “Many of these challenges manifest themselves in China,” writes Dr. Hickey, but “the challenges we see in China mirror those we see in other countries with developing regulatory systems. These issues include problems with data integrity, inadequate implementation of quality systems in manufacturing, and inconsistent regulatory oversight, among others.”

“As China’s role on the global stage expands, FDA has significantly increased drug and medical device inspections there, but we need to continue to strengthen our efforts. FDA is currently working to use Congressionally-appropriated funding to increase from eight to 27 the number of U.S. staff it posts in China.”

“FDA has established a strong working relationship with CFDA. Our office has trained hundreds of Chinese inspectors in areas that include inspecting for good manufacturing practices and assessing the quality of data from sites that conduct clinical trials.”  Read more of Dr. Hickey’s blog at link above.

Creating a New System to Improve the Security of the Drug Supply
In an April 14 FDA Voice blog, Ilisa Bernstein, Deputy Director of the Office of Compliance (CDER), discussed FDA’s new system to identify and trace prescription drugs as they are distributed within the US.  FDA is now in the standards development phase for the new system, and Bernstein indicated that stakeholder input is critical at this stage. She indicated that the implementation plan for the electronic tracking system is available on the FDA website (links available within article linked above) and that the docket is open until April 21, 2014.  FDA will host a public workshop to discuss the standards development on May 8-9, 2014, at the FDA White Oak campus (see Section 3 below).  (FDA.gov)

FDA Seeks Comment on Proposed Health IT Strategy That Aims to Promote Innovation

Bakul Patel, senior policy advisor in FDA’s Center for Devices and Radiological Health (CDRH) wrote about the proposed risk-based regulatory framework and strategy for HIT in the April 15 FDA Voice. “Health information technology (IT) offers many benefits to the American people and health care providers. Health IT products, technologies and services can prevent medical errors, improve efficiency and health care quality, reduce costs and increase consumer engagement. They also can help with identification of, and quick response to, public health threats, and further health research. But while health IT benefits are far-reaching, technology can bring risks to patients if not designed, developed, implemented, or maintained properly.”

“FDA, along with the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Communications Commission (FCC), has recently released a report outlining our proposed framework for health IT.” Patel says that the proposed framework would allow Americans to reap the benefits of health IT.  More at link above, and see Section 3 below for information on the May 13-15, 2014 public workshop on this topic. (FDA.gov)

SECTION 3 AGENCY AND ADVISORY COMMITTEE MEETINGS

Patient-Focused Drug Development: Disease Area Meetings Planned for FY2013-2015

Public Advisory Committee Meeting.  Neurological Devices Panel of the Medical Devices Advisory Committee. April 24, 2014. Gaithersburg, MD. The committee will discuss the current knowledge about the safety and effectiveness of aversive conditioning devices that are intended to deliver a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. FDA is convening this committee to seek clinical and scientific expert opinion on the risks and benefits of certain aversive conditioning devices based on available scientific data and information. [Federal Register]

Public Meeting. Meeting for Software Developers on the Common Formats for Patient Safety Data Collection and Event Reporting. April 25, 2014. Rockville, MD. Convened by AHRQ, this meeting is designed as an interactive forum where Patient Safety Organizations (PSOs – formed under the Patient Safety and Quality Improvement Act) and software developers can provide input on the formats. AHRQ especially requests participation by and input from those entities which have used AHRQ's technical specifications and implemented, or plan to implement, the formats electronically. (Federal Register)

Public Advisory Committee Meeting.  Risk Communications Advisory Committee. May 5-6, 2014.  FDA White Oak Campus, Silver Spring, MD.  The committee will meet to discuss methods for identifying the impact and increasing the reach of communications on topics of interest to consumers. The discussion will also address how FDA can evaluate whether its Consumer Updates (ForConsumers/ConsumerUpdates) are reaching the targeted population, and whether they are increasing awareness and understanding of the key risk messages. The discussion will also assess whether the communications are having the intended impact on knowledge, behaviors and/or outcomes. [Federal Register]

Public Workshop. Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format.  May 8-9, 2014.  FDA White Oak Campus, Silver Spring, MD.  This public workshop will provide a forum for discussing the development of these standards in the Drug Supply Chain Security Act of 2013. [Federal Register]

Public Workshop. IOM Workshop: “Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks in Drug Regulatory Decision-Making.”  May 12, 2014.  The purpose of the workshop is twofold: To explore potential approaches to addressing and communicating uncertainty and to identify key considerations on developing, evaluating, and incorporating potential approaches for addressing uncertainty into the assessment of benefits and risks in the human drug review process. The format of the meeting consists of a series of presentations on topics related to uncertainty in the assessment of benefits and risks, followed by a discussion on those topics with invited panelists and audience members. This workshop satisfies an FDA commitment that is part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). [Federal Register]   Note: This is DAY 2 of the meeting that was postponed from February 13th due to inclement weather.

Public Meeting on Patient-Focused Drug Development: Pulmonary Arterial Hypertension.  May 13, 2014.  FDA White Oak Campus, Silver Spring, MD.  Patient-Focused Drug Development is part of FDA’s performance commitments in the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patients’ perspectives on the impact of pulmonary arterial hypertension on daily life, as well as their perspectives on the available therapies for pulmonary arterial hypertension.

New: Public workshop. Proposed Strategy and Recommendations for a Risk-Based Framework for Food and Drug Administration Safety and Innovation Act Health Information Technology. May 13-15, 2014. National Institute of Standards and Technology, Gaithersburg, MD.  The topic to be discussed is the FDASIA Health IT report that contains a proposed strategy and recommendations on an appropriate, risk-based framework for health IT that promotes innovation, protects patient safety, and avoids regulatory duplication. [Federal Register]

Public Hearing. Generic Drug User Fee Amendments of 2012: Regulatory Science Initiatives.  May 16, 2014.  FDA White Oak Campus, Silver Spring, MD.  The public hearing will provide an overview of the current status of regulatory science initiatives for generic drugs and an opportunity for public input on research priorities in this area. FDA will take the information it obtains from the public hearing into account in developing the fiscal year (FY) 2015 Regulatory Science Plan. [Federal Register]

Public Meeting.  Study Approaches and Methods to Evaluate the Safety of Drugs and Biological Products During Pregnancy in the Post Approval Setting.  May 28-29, 2014. FDA White Oak Campus, Silver Spring, MD.  The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, researchers, the pharmaceutical industry, public health agencies, health care providers, and the general public concerning challenges in designing and implementing pregnancy registries and other methods of evaluating the post-approval safety profile of drugs and biological products in pregnant women. The input from this meeting and public docket will be used to support the revision of a guidance for industry on establishing pregnancy exposure registries.  [Federal Register]

Symposium. 2014 Medical Countermeasures Initiative Regulatory Science Symposium. June 2-3, 2014. FDA White Oak Campus, Silver Spring, MD.  The symposium is intended to provide a forum for the exchange of scientific ideas for medical countermeasure development and evaluation, communicate progress on regulatory science efforts related to the development and advancement of medical countermeasures, facilitate innovative directions, and inform stakeholders on medical countermeasure-related scientific progress and accomplishments. [Federal Register]

Public workshop. Advancing the Development of Pediatric Therapeutics (ADEPT): Pediatric Bone Health. June 3, 2014. FDA White Oak Campus, Silver Spring, MD.  The purpose of this initial workshop is to provide a forum to consider issues related to advancing pediatric regulatory science in the evaluation of bone health in pediatric patients. [FDA.gov]

Public Workshop.  Immune Responses to Enzymes Replacement Therapies: Role of Immune Tolerance Induction.  FDA White Oak Campus, Silver Spring, MD. June 9, 2014. The workshop will provide a forum to discuss the role of immune tolerance induction in patients receiving replacement biological products. (FDA.gov)

Public Meeting. Inborn Errors of Metabolism Patient-Focused Drug Development. June 10, 2014. FDA White Oak Campus, Silver Spring, MD.  This public meeting will address Patient-Focused Drug Development for neurological manifestations of inborn errors of metabolism. FDA is interested in obtaining patient input on the impact of the neurological manifestations of inborn errors of metabolism on daily life and patient views on treatment options. [FDA.gov]

Public Meeting.  National Cancer Institute (NCI) Clinical Trials and Translational Research Advisory Committee.  July 16, 2014. NIH, Bethesda, MD.  Agenda: Strategic Discussion of NCI’s Clinical and Translational Research Programs. The meeting will be open to the public, with attendance limited to space available. [Federal Register]

SECTION 4 OTHER REGULATORY AUTHORITIES & ORGANIZATIONS

Cancer Doctors Plan to Compare Value of Expensive Drugs

The world’s largest organization of cancer doctors plans to rate the cost effectiveness of expensive oncology drugs, and will urge physicians to use the ratings to discuss the costs with their patients.

The American Society of Clinical Oncology is weighing efficacy, side effects and price using an algorithm to determine the relative value of drugs, focusing first on therapies for advanced cases of lung and prostate cancer and for multiple myeloma, said Richard Schilsky, the group’s chief medical officer. The task force developing the system plans to present it for public comment later this year, he said. More at link above. (Bloomberg)

ACC, AHA to start including cost/value assessments
The American College of Cardiology and American Heart Association are the latest physician groups to integrate value assessments for treatments into clinical practice guidelines and performance measures. In a joint statement published in Circulation and the Journal of the American College of Cardiology, the groups cited the "need for more explicit and transparent assessment" of value and proposed using quality-adjusted life year (QALY) measures to sort treatments into "level of value" categories. The groups -- which currently only explicitly consider clinical efficacy and outcomes -- did not provide specifics or a time frame for implementing the change.  More at title link.  (BioCentury)

VA: doctors should defer HCV treatment for some
The U.S. Department of Veteran Affairs recommended regimens containing Sovaldi sofosbuvir from Gilead Sciences Inc. and Olysio simeprevir from Johnson & Johnson for most HCV patients, but said it would be "reasonable" for doctors to defer treatment for some patients until newer therapies are available. According to new treatment guidelines released by the VA, physicians should take into account stage of liver fibrosis and whether a patient has cirrhosis or hepatocellular carcinoma (HCC) when deciding whether to wait for new interferon-free and ribavirin-free regimens, which the VA said are expected to be safer and less complex to administer and are expected to be approved in the next 12-24 months. More at title link above.  (BioCentury)

Medicare Payment Data Released: Journalists Create National and Regional Searchable Databases, Often with Little Context for Payments

On April 9th, the Centers for Medicare and Medicaid Services (CMS) released the 2012 Medicare billing information for individual doctors. Overall, the data cover $77 billion in billing involving 880,000 practitioners. CMS released their data in a dozen giant, difficult-to-read spreadsheets.

Simultaneous with the news coverage, however, several national publications created user-friendly databases for the public to explore.  Soon after the national news outlets covered the release of Medicare payments, regional newspapers began to seize the opportunity as well.  Indeed, countless articles across the country ran variations of "Find Out How Much Your Doctor Receives from Medicare."

Proponents of transparency argue that the public release of Medicare data could put pressure on healthcare providers to rein in overtreatment and the use of unnecessarily expensive procedures. The data could also potentially steer patients to the most "experienced" doctors, if judged purely on the number of Medicare-paid procedures. However, without more context, the data is both unclear and unduly prejudicial to many physicians—especially those who practice in high-cost, specialized areas or who simply see a lot of patients.  More at link above. (Policy and Medicine)
 
Health Canada Issues Revised Product Monograph
Last week, Health Canada issued a revised Guidance Document entitled, “Product Monograph.”  The purpose of this guidance document is to emphasize clinical relevance, make information easier to retrieve and provide format and information consistency across different drugs and drug classes.  (NSF Health Sciences Daily Dose)

ICH E2C(R2) Q&As available on the ICH website

In November 2012, the ICH Steering Committee endorsed the establishment of the IWG on E2C(R2) to assist with the implementation of the new revision (R2) of the E2C Guideline finalized under Step 4 of the ICH Process in November 2012. This revision to E2C has introduced new concepts and principles linked to an evolution of the traditional PSUR from an interval safety report to cumulative benefit-risk report (PBRER) and with a change in focus from individual case reports to more aggregate data evaluation.

This supplementary Questions and Answers document finalized under Step 4 in March 2014 intends to clarify key issues.  (ICH.org)

EMA and EU national competent authorities agree on action plan to address medication errors

The European Medicines Agency and the National Competent Authorities of the European Union (EU) have agreed an action plan to address the issue of medication errors, a major public-health burden.

The overall objective of this plan is to facilitate the availability of tools to ensure that cases of medication errors causing harm are reported at national and EU level in compliance with the EU pharmacovigilance legislation and to optimize risk minimization and/or prevention measures with regard to medication errors.

In 2013, the EMA organized a workshop that brought together more than 240 participants from various stakeholder groups to determine a way forward for better reporting and prevention of medication errors.

Six key recommendations resulted from the discussions. The action plan published today foresees the development of guidance and other documents that aim to implement these recommendations for delivery by September 2015. More at link above.  (EMA.europa.eu)

EU agrees joint drugs/vaccines purchasing deal

The European Commission has now approved a Joint Procurement Agreement under which all European Union (EU) member states will be able to procure pandemic vaccines and other medicines as a group rather than individually.

The agreement will enable member states to ensure that pandemic vaccines and medicines are available in sufficient quantities and at a “correct” price, should a cross-border health threat emerge, and it will benefit all EU countries, particularly those which encountered difficulties in purchasing vaccines developed for the H1N1 (swine flu) pandemic in 2009, says the Commission.

The potential of the accord reaches beyond vaccines for pandemics – member states could benefit from extending the agreement to cover the purchase of medical countermeasures for other infectious diseases such as botulism, anthrax, hepatitis B or polio, officials point out.

27 member states have so far declared their intention to sign the Agreement, which is voluntary and will enter into force two weeks after it has been signed by a third of participating member states (10 countries) and the Commission. More at link above. (PharmaTimes)

EMA and Australian regulator strengthen collaboration in the area of orphan medicines

The EMA and TGA have announced that the two regulators have agreed to share the full assessment reports related to marketing authorizations of orphan medicines, which are intended to treat rare diseases.

If the same marketing-authorisation application is received in parallel by EMA and TGA, the two regulators have the possibility of scientific exchange to facilitate the evaluation of the medicine. Both regulators will still reach their own conclusions about the suitability of each medicine to be authorised in their respective markets.  More at link above.  (EMA.europa.eu)

TGA opens upgraded over-the-counter medicines online application system
The Therapeutic Goods Administration (TGA) of Australia has opened the upgraded over-the-counter medicines online application system, effective April 9.  “ Applications will be easier to submit and process and industry will benefit from this reduction in regulatory burden.”  This upgrade is part of the staged implementation of the harmonization of OTC medicines business processes in Australia and New Zealand. More at link above. (TGA Press Release)

NHS England will pay for hep C drug Sovaldi
An investment of more than $31 million was approved by NHS England to pay for Gilead Sciences' hepatitis C drug Sovaldi, or sofosbuvir. The decision is expected to benefit about 500 patients awaiting liver transplantation and those with acute liver failure. "[W]e will ensure that clinicians are aware of this policy, so that all eligible patients have the opportunity to access this drug," said James Palmer, the agency's clinical director of specialized services. (PharmaTimes (U.K.))

Britain to build new biologics center

Britain has begun construction of the new $64 million National Biologics Manufacturing Centre, which will help companies develop and test vaccines and other medications made by biological means. The facility is scheduled to be completed next year. "The NBMC is an excellent opportunity to bring industry, academia and the funding agencies together to create the best possible environment for UK Biotechnology to grow," said Steve Bagshaw, CEO of Fujifilm Diosynth Biotechnologies. (FDLI SmartBrief)

Anvisa Expedites Device Imports
Brazil’s national regulatory agency, Anvisa, has expedited the process for importing high-risk medical devices (Class III and IV) by agreeing to initiate the review of such devices pending the grant of the Certificate of Good Manufacturing Practices (CBPF) for the foreign manufacturing site. According to Anvisa, under the revised procedure (RDC 15/2014), new high tech devices should enter the Brazilian market sooner, since the analysis of the device by the agency can proceed while the manufacturing site awaits CBPF certification. Moreover, lower risk devices, such as gloves, syringes and some surgical instruments, will no longer require CBPF certification prior to import, which will eliminate about 25% of the CBPF certification applications received by the agency. (RegLinkAssociates)

CFDA Targets Counterfeit Internet Sales
At the April 8 China FDA (CFDA) and provincial agencies teleconference on Internet advertising enforcement, CFDA Vice Minister Liu Peizhi called for strengthening joint supervision and joint law enforcement between the national and provincial agencies. He pointed out that currently there are 600 million Internet users in China and that 68% of the world's counterfeit drugs are sold through the Internet. China’s food and drug regulatory authorities have grasped the nature of radio, television, newspapers, traditional media advertising, he said, but now must study the characteristics of the new media and how to find and prosecute illegal advertising and sales of drugs, medical devices, health food and non-pharmaceutical drugs on the Internet. (RegLinkAssociates)


SECTION 5 LEGAL, POLICY, AND COMPLIANCE NEWS

Senator Grassley Announces Plans to Create Whistleblower Caucus
Senator Chuck Grassley (R-Iowa) plans to create a "Senate Whistleblower Protection Caucus." Grassley's plan coincides with the 25th anniversary of the Whistleblower Protection Act, which he co-authored. Over the next six months, Grassley will discuss the caucus with colleagues and encourage them to join with an eye on an official start in the new Congress, according to an announcement by the Congressman's office. "Whistleblower protections are only worth anything if they're enforced," Grassley stated. "Just because we've passed good laws does not mean we can stop paying attention to the issue. There must be vigilant oversight by Congress. The best protection for a whistleblower is a culture of understanding and respecting the right to blow the whistle." He added that he hopes "this whistleblower caucus will send the message that Congress expects that kind of culture."  More at link above. (Policy and Medicine)

Mass. ban on painkiller Zohydro reversed by federal judge

Massachusetts Gov. Deval Patrick's effort to prohibit sales of the controversial pain treatment Zohydro was blocked Tuesday by U.S. District Judge Rya Zobel, saying Patrick had no right to ban a drug deemed effective and safe by the FDA. Allowing Patrick's emergency order against the drug to stand "would undermine the FDA's ability to make drugs available to promote and protect the public health," Zobel wrote in a five-page order. "Although the ban may prevent someone from misusing the drug, the ban prevents all in need of its special attributes from receiving the pain relief Zohydro ER offers." (FDLI SmartBrief)

Arizona Compassionate Use Bill Advances

The Arizona Senate passed a bill that would allow physicians to prescribe investigational products to eligible terminally ill patients who have no "comparable or satisfactory" FDA-approved treatment options. The bill would prohibit the state from taking any action against a doctor or health care institution that prescribes or treats a patient with an investigational treatment, defined as a drug, biologic or device that has completed Phase I testing but does not have FDA approval. The Arizona House of Representatives has already passed the bill, which now goes to Gov. Janice Brewer. If she does not veto the bill, it will be subject to voter approval in the state's November general election.

Similar bills are moving through the legislatures of at least two other states: Louisiana and Missouri. (BioCentury)


SECTION 6 SOURCES REVIEWED FOR THIS NEWSLETTER

A partial listing of sources reviewed for this newsletter:  AdvaMed Smartbrief; AHRQ Newsletter; Alzheimers Association; Alzheimers Research Forum Newsletter; BioCentury; Biopharma Reporter; BIOtechNow; CDISC Monthly Newsletter; CER Daily Newsfeed (NPC); Daily Dose (Becker); DIA Daily; Drug Daily Bulletin;  EMA website; EP Vantage; Evaluate Pharma; Eye on FDA; FDA.gov; FDA Law Blog; Federal Register Table of Contents; Fierce Medical Devices; Fierce Pharma; Fierce Vaccines; FDLI Smartbrief; Genomeweb; Health Industry Washington Watch; Government Health IT; Health IT Security; Institute of Medicine News; MedCityNews; Medical Device Daily; Medical Device & Diagnostic Industry; MedPage Today; NPC Bulletin; Nutra Ingredients USA; Pharmabiz; Pharmafile; Pharma IQ; PharmaTimes; PhRMA website; PM Live; Policy and Medicine (newsletter); Regulatory Focus; RegLink News; US FDA Daily Digest Bulletin.