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Accelerated Approval Labeling Changes Take Shape In Recent Approvals

 
• By Sarah Karlin-Smith

FDA has started implementing changes called for in a draft guidance on labeling of drugs granted accelerated approval throughout the last three-quarters of 2014, without waiting for the final guidance or even the comment period to close.

FDA appears to have adopted a new practice for labeling drugs cleared under accelerated approval that more transparently communicates the conditional nature of such approvals – putting into practice changes laid out in a draft guidance released in March 2014 that haven’t yet been made official.

The agency has actually been shifting its practice throughout the last nine months of 2014. All eight drugs granted accelerated...

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US Strategic Reserve Bulking Up: New Order Focuses On API Stockpile

 
• By Laura Helbling

The White House is directing the Health and Human Services Department to replenish stockpiles of active pharmaceutical ingredients for “especially critical” medicines.

Medicare Part D Plans Turn to Coinsurance, Higher Deductibles Amid IRA Changes

 
• By Tim Casey

Newly implemented IRA provisions may not necessarily lower drug costs for those enrolled in Medicare Part D plans, according to research by the USC Schaeffer Center for Health Policy and Economics.

Selective Safety Data Collection In Clinical Trials: Adoption Lags Despite Benefits, US FDA Says

 
• By Manas Mishra

Lack of awareness is limiting use of guidelines that simplify safety reporting for some late-stage trials, FDA says, while also highlighting wins. Boehringer experienced mixed results, while Novartis, Lilly, and Merck were more successful, and Roche should have probably tried, white paper suggests.