Despite generic industry requests for FDA to allow flexibility in generic product design, the agency declined to make any major modifications to its draft guidance on the size, shape and other physical characteristics of generic tablets and capsules.
Generic Firms Fear 'New Lifecycle Management Tool' From FDA Pill Size Guidance
Final guidance excludes attachment on capsules but otherwise is virtually identical to draft; GPhA had argued for flexibility in product design to avoid brand patents.
More from United States
• By
Pharma executives and investors are waiting with bated breath to find out if President Trump will include drugs in a new round of tariffs to be announced on 2 April.
• By
One CDRH employee said the cuts already are having a major effect on morale.
• By
Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
• By
Experts say PBMs should become familiar with transparency rules and prepare to release data, although more legal wrangling could occur.
More from North America
• By
Optum Rx, one of the largest PBMs in the US, declared it was the “first comprehensive, transparent pharmacy services company” after announcing several consumer-friendly changes.
• By
FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.
• By
In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."