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Abraxane White Paper Distribution At ASCO Draws FDA Advertising Letter

 
• By Brenda Sandburg

Celgene says the white paper – which FDA says promotes Abaxane as effective for unapproved uses and superior to Bristol-Myers Squibb’s Taxol – was intended solely for potential business partners interested in nab technology.

Firms need to be more restrictive in how they distribute business development materials at medical conferences, an FDA advertising letter to Celgene Corp.suggests.

In the untitled letter, dated Dec. 23, the agency objects to a white paper about Abraxane...

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More from United States

Oncology: Plan Ahead To Rule Out Harm When Survival Not The Endpoint, US FDA Says

 
• By Michael McCaughan

The FDA recommended sponsors plan ahead for potential issues if overall survival is not feasible as a primary or secondary efficacy endpoint in clinical trials and must be analyzed as a safety outcome.

Changes In Pediatric COVID-19 Vaccine Recommendations Causing Coverage Confusion

 
• By Sue Sutter

The CDC’s current shared clinical decision-making recommendation for vaccinating healthy children age six months and older should trigger full coverage under the Affordable Care Act, but is not always happening at pharmacies and doctors’ offices, an Epstein Becker attorney said.

US FDA Suspends Valneva’s Ixchiq Based On Four New Serious AE Reports

 
• By Sue Sutter

After an Aug. 6 safety labeling change, the FDA became aware of “more compelling evidence” that the risk for serious chikungunya-like illness is not limited to older adults, CBER Director Prasad said.

Generic Industry Looking For Expanded Inspections As US FDA Rehires Staff

 
• By Grace Moser

Generic drug industry representatives applauded the FDA decision to bring back key staff in the Office of Generic Drugs that were laid off earlier this year.

More from North America

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.