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FDA Should Drop Ban On Office Compounding, US House Members Say

 
• By Joanne S. Eglovitch

Commissioner Gottlieb stands pat (actually he was sitting) during hearing where lawmakers suggest FDA has gone overboard in implementing DQSA. And while he acknowledges that '503 lite' isn't the best term to use, Gottlieb says agency’s plan to create different risk tiers for drug outsourcing pharmacies offers the flexibility that can entice more traditional pharmacies to register as outsourcing centers, and thus be subject to GMP oversight.

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The US FDA was admonished Jan. 30 by a score of lawmakers who argued that banning the practice of compounding drugs for office use and creating different risk tiers for drug outsourcing pharmacies to entice more traditional pharmacies to register are bad policies that could have negative implications for the public health.

But Commissioner Scott Gottlieb stood his ground during the hearing by House Energy and Commerce Subcommittee on Health, saying that...

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• By Eliza Slawther

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EU Pharma Reform: Lawyers Unpack Diverging Visions For Innovation

 
• By Eliza Slawther

There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.

UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 
• By Eliza Slawther

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

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ACIP ‘Pivot’ May Mean Variable US Coverage For New Vaccines, Higher Copays

 
• By Cathy Kelly

Clarity on payer responses to controversial vaccine recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices may be coming.

CAR-T Therapy Trials Involving Chinese Labs Will Face Heightened US FDA Scrutiny

 
• By Michael McCaughan

The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.

New CDER Deputy Director Michael Davis Brings Psychedelic Drug Development Experience

 
• By Sue Sutter

Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.