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FDA Latest Opioid Dilemma: Can Apadaz Stop Snorting Abuse – And Does That Even Matter?

 
• By Brenda Sandburg

KemPharm's immediate-release hydrocodone combination product has limited data about a route of abuse that FDA believes is a relatively small aspect of the epidemic.

FDA's decision on whether to approve KemPharm Inc.'s Apadaz immediate-release hydrocodone combination product appears to depend on the value of its ability to deter snorting abuse. Unfortunately for the company, the agency suggests that the available data may be too limited to provide a definitive answer, and the proposed post-marketing studies wouldn't resolve the question either.

The Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees will convene May 5 to consider three questions

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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 Beleagured 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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