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Manufacturing Compliance Updates In Brief: A Reduced Focus On Data Integrity

 
• By Joanne S. Eglovitch

US FDA has issued at least 10 GMP warning letters in February and March to drug and API manufacturers in China, India, France, South Korea, Hong Kong, the Dominican Republic and the US. Common problems seen are failure to validate manufacturing processes, inadequate testing to conform that products meet specifications, and inadequate safeguards to prevent microbiological contamination, yet in a recent turn, only a few manufacturers had data integrity problems. FDA posts Form 483 reports issued to four manufacturers in India for GMP violations and adds six facilities to its drug GMP import alert.

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The predominance of data integrity issues in FDA drug GMP warning letters appeared to diminish in February and March, when there was a greater focus on traditional manufacturing quality issues. Typical issues raised in 10 warning letters issued during that span include failure to validate manufacturing processes, inadequate testing to confirm that products meet specifications, and inadequate safeguards to prevent microbiological contamination.

FDA also posted Form 483 reports issued to four manufacturers in India for GMP violations and added six facilities to its drug GMP import alert.

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Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
• By Sarah Karlin-Smith

The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.

Sarfez Pharma’s Promotional Claims For Diuretic Soaanz Draw US FDA Warning Letter

 
• By Sue Sutter

Webpages, a healthcare professional pamphlet and a medical conference exhibit booth panel make unsupported comparative superiority claims about generic torsemide products and misrepresent risks, the Office of Prescription Drug Promotion says in its first warning letter of 2025.

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By Cathy Kelly

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

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Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

Pfizer’s All-Comers CRPC Dream For Talzenna Quashed For Lack Of Biomarker-Negative Rigor

 
• By Bridget Silverman

The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.