Generic firms argue their data is not sufficient to recommend safety labeling changes, but FDA’s Dal Pan asks if they recommend changes in other countries, shouldn’t they be able to do the same in the US?
FDA officials questioned why the generic industry feels its pharmacovigilance information is sufficient to suggest labeling changes in other countries, but inadequate for the same task in the U.S., which would be required under the proposed generic labeling reg.
A number of generic company representatives said during a March 27 public meeting on the controversial proposed rule that it...
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.
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.
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 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.
The White House is directing the Health and Human Services Department to replenish stockpiles of active pharmaceutical ingredients for “especially critical” medicines.
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.
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.
