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GMP Flexibility For Compounders Signaled In FDA Draft Guidance

 
• By Derrick Gingery

Agency seeks comments on how to minimize burden of some testing requirements for registered outsourcing facilities.

FDA appears willing to allow some flexibility for compounders who must adhere to Good Manufacturing Practices, allowing for potential alternatives to minimize the burden of some testing requirements.

New draft guidance on GMPs for outsourcing facilities sets interim standards for compounders registered with the agency under the Drug...

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More from United States

Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

 
• By Sarah Karlin-Smith

The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By Sue Sutter

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

US Budget Bill Eases IRA Price Controls But Coverage Losses Will Impact Pharma

 
• By Cathy Kelly

The legislation expected to be signed by President Trump is a mixed bag for pharmaceutical manufacturers depending on their product mix and manufacturing situation.

How Could MFN Pricing Impact Commercial Market?

 
• By Angela Maas

Industry experts forecast the impact of President Trump's Most-Favored Nation drug pricing policy on the commercial insurance industry.

More from North America

How Could MFN Pricing Impact Commercial Market?

 
• By Angela Maas

Industry experts forecast the impact of President Trump's Most-Favored Nation drug pricing policy on the commercial insurance industry.

COVID-19 mRNA Vaccine Labels Now Quantify Myocarditis Risk, But ACIP Wants Other Changes

 
• By Sue Sutter

New members of the CDC’s Advisory Committee on Immunization Practices suggested concerns beyond myocarditis, questioning whether test-negative observational studies are giving an incorrect picture of effectiveness.

Medicare’s Combo Products Negotiation Plan Conflicts With US FDA Standards, Firms Argue

 
• By Cathy Kelly

The plan could curtail a period of pricing flexibility for newer subcutaneous versions of important oncology drugs.