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FDA Wants Compounding Authority Clarified, Congress Not So Sure It’s Necessary

 
• By Derrick Gingery

Commissioner Hamburg asks for more power over non-traditional compounding to better regulate companies like the New England Compounding Center, but several House members say it looks like the agency already has the authority it needs.

FDA is arguing for more authority over some types of compounding to prevent future problems like the deadly meningitis outbreak at the New England Compounding Center, but many House members are not convinced it is necessary.

Several Republican members of the House Energy and Commerce Committee Oversight and Investigations Committee suggested during a Nov. 14 hearing...

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More from United States

CAR-T REMS Removal Should Boost Access, But Long-Term Follow-Up, Black Box Remain

 
• By Sarah Karlin-Smith

The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

PDUFA VIII: Cutting Perceived Conflict Of Interest May Be A Theme

 
• By Derrick Gingery

Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.

US CDC Vaccine Committee Revives Thimerosal Debate: A Portent Of Things To Come?

 
• By Bridget Silverman

The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.

More from North America

Merck’s Clesrovimab Vote Reflects New ACIP Members’ Skepticism

 
• By Sue Sutter

The new Advisory Committee on Immunization Practices members endorsed Merck & Co.’s monoclonal antibody for RSV prevention, but some questioned its use in healthy babies and potential interactions with vaccines given at the same time.

Oz Says Big PBMs Have ‘Window’ to Quit Rebate System on Their Own

 
• By Leslie Small

CMS Administrator Mehmet Oz said PBMs may deserve "one last chance" to fix the rebate system before federal regulations and legislation are enacted.

Canada Unveils Draft List of Essential Drugs For Universal Pharmacare

 
• By Neena Brizmohun

The list of essential prescription drugs and related products will shape Canada’s first national formulary for the country’s universal pharmacare program.