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From Capitol Hill to the antiseptic halls of the FDA to the more rarefied surroundings of academia, there is increasing scrutiny of the ways in which clinical trials are conducted and what becomes of the data resulting from those trials.
Mylan Pharmaceuticals will appeal a federal court ruling that prevents it from launching a version of Johnson & Johnson’s pain-drug patch, Duragesic (fentanyl), ahead of the generic competition.
The FDA should delay its decision on a widely watched follow-on biologics application until after the agency holds a meeting next month on the scientific issues related to follow-on biologics and develops a draft guidance next year on how to approve versions of the complex proteins, according to Pfizer.
The FDA’s decision not to list a patent for Forest Laboratories’ depression drug Celexa in the agency’s Orange Book did not violate the law, a federal court has ruled.
The FDA has abandoned its own precedent that authorized generics are functionally and legally equivalent to true generics, Mylan Pharmaceuticals argues in a lawsuit that alleges the agency improperly allowed a brand-authorized generic to launch during Mylan’s generic marketing exclusivity period for the same drug.
HHS and the FDA said they would “vigorously” defend themselves against allegations that the agencies are not acting quickly enough to establish a program that would allow the legal importation of prescription drugs from Canada.
The manufacturers of the dietary supplement ephedra have asked a U.S. District Court to invalidate the FDA rule banning the substance and to enjoin the FDA from enforcement action against the plaintiffs for the continued sale of ephedra in low doses.
Despite a growing demand for what still are illegally imported prescription drugs and the abetting of such importation by a growing number of state and local governments, the FDA is not giving up the fight.
The FDA has concluded there is evidence to suggest an increased risk of suicidal behavior for children using certain antidepressant medications, a conclusion that at least partially vindicates findings made by FDA scientist Andrew Mosholder months ago.