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A recent report suggests the advisory committees that the FDA relies upon to ensure medical products are safe and effective can be wildly inconsistent in their recommended approval rates. Read More
A month after the FDA announced a nationwide sweep that resulted in criminal and civil cases against 89 makers of dietary supplements, a former owner and operator of a Montana dietary supplement maker has been sentenced to prison for selling supplements in violation of two court orders. Read More
An FDA advisory committee Tuesday erected another roadblock for getting Fabre-Kramer’s depression candidate gepirone on the market, recommending against approving a potential therapy whose fate has been in limbo for two decades. Read More
Gilead Sciences put profit over affordability when pricing its line of hepatitis C treatments, says a Senate Finance Committee report issued Tuesday. Read More
The FDA has underestimated the burden that would be imposed on drug manufacturers in collecting and reporting quality metrics data, industry says in comments on the agency’s quality metrics draft guidance. Read More
Fabre-Kramer Pharmaceutical’s depression candidate gepirone could be held back yet again in its fourth go-around, with the FDA questioning whether two successful trials are enough to prove its value alongside a “relatively large” number of negative trials. Read More
Drugmakers facing a European GMP inspection should be prepared to provide complete documentation of active ingredients throughout the supply chain, going back to the starting materials that were used in the synthesis of the APIs. Read More
With a mixed bag of results and much at stake for BioMarin’s Duchenne muscular dystrophy treatment drisapersen, FDA reviewers overwhelmingly decided the largest, most complete trial in the drug’s development weakened “promising” findings from earlier studies. Read More
Two senators are pressing the Department of Health and Human Services to authorize prescription drug importation from Canada to combat price gouging in the marketplace. Read More