Becker Daily Dose January 27, 2012

Today, FDA announced the reopening of the comment period for the proposed rule entitled, “Direct-to-Consumer (DTC) Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner.” The agency is looking for data to establish standards that would be considered in determining whether the major statement in DTC advertisements relating to side effects and contraindications of an advertised prescription drug is presented in a clear, conspicuous and neutral way.

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Becker 2012 Team Kickoff

Looking forward to working together with you to make 2012 a productive and successful year.

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Becker Daily Dose January 26, 2012

FDA’s Center for Devices and Radiological Health (CDRH) released its 2012 strategic priorities focusing on four areas: implementing a total product life cycle approach, enhancing its internal and external communication and transparency, strengthening its workforce, and proactively facilitating innovation. The initiatives include a pilot program set to begin April 1, 2012 to triage premarket applications to increase review efficiency, and a proposal by December 31, 2012 to clarify the circumstances when CDRH could rely on clinical studies conducted in and for other countries.

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Becker Daily Dose January 25, 2012

Today, FDA announced the availability of additional draft and revised draft recommendations for the design of product-specific bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). The new BE recommendations are published on FDA’s website, and were developed via the process described in the May 2007 draft guidance document entitled, “Bioequivalence Recommendations for Specific Products.”

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Becker Daily Dose January 24, 2012

The US court of appeals for the DC Circuit, upheld a lower court’s decision that manufacturers cannot sue FDA on the basis of warning letters. The ruling, which resulted from a case where manufacturers and distributors of ear candles sued FDA for violation of First Amendment rights, affirms that warning letters are not subject to judicial review because they do not constitute “final agency action.”

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Becker Daily Dose January 23, 2012

On Friday, FDA allowed marketing of the STRATIFY JCV™ Antibody ELISA test, the first test designed to help determine the risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri to treat multiple sclerosis (MS) or Crohn’s Disease (CD). The STRATIFY JCV Antibody ELISA test, when analyzed in light of other clinical factors of the patient, can allow physicians and patients to assess the risk for developing PML, and provide better insight into the benefits of continuing Tysabri treatment in these patients.

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Staff News

Harold "Wally" Pellerite, Director of the Medical Device Compliance Committee at Becker Consulting, will speak on a panel during the “Enforcement, Litigation and Compliance Conference” held by the Food and Drug Law Institute (FDLI) on December 6-7, 2011, at the Westin Georgetown in Washington, DC.   Mr. Pellerite will be discussing quality and recall issues during the December 6 afternoon panel on “Medical Product Safety.”

Conference Information

Staff News

Ron Ginor, MD, Chief Executive Officer of Becker Consulting, spoke on a panel during the “Issues in Global Health: Advancing Efficiency and Quality through Regulatory Science” symposium sponsored by the Johns Hopkins Carey Business School and the Food and Drug Law Institute (FDLI) on December 2, 2011, at the National Press Club in Washington, DC.   Dr. Ginor used case studies and recent examples to speak to the regulatory realities facing manufacturers and affecting public health officials during the second morning panel on “Realities of Global Compliance.”  

Presentation
JHU News Release
Symposium Information

FDA Draft Appeal Guidance Released

FDA’s recent draft guidance document on the process for appealing decisions by the Center for Devices and Radiological Health (CDRH) is intended to clarify the options for having a decision by CDRH reviewed or reconsidered.  According to Jeffrey Shapiro, an attorney with Hyman, Phelps & McNamara, the guidance is helpful in providing a detailed description of the currently available avenues for appeal, but does not reform the process or otherwise address industry complaints including the slowness of the appeals process and potential conflicts of interest involving agency staff who review the appeals.  (The Gray Sheet)

Draft Guidance

Press Release

Becker & Associates Consulting, Inc. (Becker Consulting) is proud to announce the addition of Tim Ulatowski, former Director of the Office of Compliance within the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA), as Director, Medical Devices on the Becker Consulting Expert Advisory Committee.  Mr. Ulatowski has over 36 years of public health experience, including more than 25 years in multiple leadership positions at FDA’s CDRH.  

Press Release

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The Becker™ Daily Dose™ keeps readers informed with the latest FDA regulatory and compliance news, important policy and legislation updates, and coverage of upcoming panels and meetings.  





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