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Drug Shortages: Generic Industry’s Self Regulation Proposal Questioned At House Hearing

 
• By Derrick Gingery

Mylan’s Heather Bresch still has questions and House members ask whether it could coexist with mandatory FDA reporting legislation.

Industry and government questions about the generic industry’s idea to have a third party administer drug shortage data likely must be answered before it could be linked to a congressional mandate to expand shortage reporting to FDA.

Members of the House Energy and Commerce Health Subcommittee seemed interested in the Generic Pharmaceutical Association’s “Accelerated Recovery Initiative” idea for an independent entity to hold and disseminate data supply information that could predict and help mitigate shortages

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Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

US FDA Restoring Some Library Resources

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.

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