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FDA Mandates Need Accompanying Resources, Hamburg Says

 
• By Derrick Gingery

The mandates in the FDA Safety and Innovation Act and Drug Quality and Security Act show a lot of congressional confidence in the agency, but FDA commissioner says that members also must provide resources to go with it.

Commissioner Margaret Hamburg reminded Congress that additional mandates require resources to go with them.

Congress has shown its confidence in FDA with legislation like the recently enacted Drug Quality and Security Act expanding regulation of compounding and drug shipment tracking

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More from United States

US FDA Rare Disease Case Studies Provide Development Models For Sponsors

 
• By Laura Helbling

Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.

House Budget Bill Includes Delayed Orphan Fix, Also Risks Downstream Cell and Gene Coverage

 
• By Sarah Karlin-Smith

The first two classes of negotiated drugs under the Inflation Reduction Act would not benefit from a rare disease adjustment House Republicans included in their reconciliation package.

Trump’s Rx Pricing Order: The Best-Case And Worst-Case Scenarios

 
• By Derrick Gingery

US trade and tariff leverage might successfully push European and other countries to pay more for medicines, but if not, President Trump’s executive order includes potential US drug withdrawal and other options to entice industry to lower US prices.

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.

More from North America

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.