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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in collecting and reporting quality metrics data, industry says in comments on the agency’s quality metrics draft guidance.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
During clinical development, biosimilars makers can request as many meetings with FDA reviewers as necessary but they need to be outcomes-based with a priority on narrowly defined questions that the FDA can answer. Read More
Drugmakers engaging in anticompetitive practices don’t get a free pass simply because federal regulators failed to act, the Federal Trade Commission has asserted in a pending court case. Read More
The majority of the Senate Committee on Health, Education, Labor and Pensions, from both sides of the aisle, supported Robert Califf’s nomination as the next FDA commissioner during a two-hour confirmation hearing Nov. 17. Read More
Biosimilars experts concluded that fostering the nascent industry would require many of the same elements that originally nurtured the generics industry: educational efforts, regulatory and patent changes, and most importantly, patience. Read More