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Sterile Compounders Would Get Tailored Manufacturing Regs If FDA Gets New Authority

 
• By Derrick Gingery

FDA’s Woodcock says large-scale compounders would not be subject to all current Good Manufacturing Practices, but would be given separate regulations tailored specifically for them, similar to how it handled PET drug requirements.

FDA intends to design regulatory standards for large-scale compounding manufacturers, rather than subject them to all current Good Manufacturing Practices, if a draft Senate bill to expand agency oversight of the industry is enacted.

Questions remain, however, about whether the additional oversight proposed in the bill should go into effect right away or after...

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More from United States

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.

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.

New CDC Vaccine Panel Chair Vows To ‘Rebuild Public Trust’ With Evidence-Based Medicine

 
• By Sue Sutter

The newly reconstituted Advisory Committee on Immunization Practices will create new work groups to examine the cumulative impact of vaccine schedules and reexamine some older vaccines.

More from North America

New CDC Vaccine Panel Chair Vows To ‘Rebuild Public Trust’ With Evidence-Based Medicine

 
• By Sue Sutter

The newly reconstituted Advisory Committee on Immunization Practices will create new work groups to examine the cumulative impact of vaccine schedules and reexamine some older vaccines.

Cassidy Confirms Agreement With Kennedy Did Not Include Maintaining CDC Vaccine Advisors

 
• By Sarah Karlin-Smith

Sen. Bill Cassidy and HHS Secretary Robert F. Kennedy Jr. agree the disbanding of ACIP did not violate their agreement, but the perception that Kennedy is not following the spirit of the pledge could be more important long-term.

ACIP Members ‘Not Easy’ To Find After Clean Sweep, US CDC Director Nominee Says

 
• By Cathy Kelly

The CDC Advisory Committee on Immunization Practices had only seven members in place as it met for the first time since HHS Secretary Robert F. Kennedy Jr. dismissed the previous panelists. CDC Director nominee Susan Monarez said finding replacements has been difficult.