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The judge overseeing the Center for Reproductive Rights’ (CRR) lawsuit against the FDA granted the center’s request for discovery of additional agency documents, but put a stay on documents the group sought from the White House.
A forceful “culture of approval” and attempts to muffle scientific dissent among agency reviewers have created significant problems in the FDA’s drug review process, witnesses at a House subcommittee hearing testified.
Federal investigators from the FDA’s Office of Criminal Investigations unexpectedly showed up Feb. 14 to conduct a full-scale search of Ranbaxy offices and a manufacturing plant in New Jersey, company sources said.
The U.S. Food and Drug Administration (FDA) issued a draft guidance with recommendations on how blood product manufacturers can apply for licenses to use placental or umbilical cord blood treatments for hematological malignancies.
The FDA wants to prohibit certain cattle materials from drugs, biologics and medical devices to lower the risk of bovine spongiform encephalopathy (BSE or mad cow disease).
Improved drug safety is foremost in the FDA’s Prescription Drug User Fee Act (PDUFA) proposal that seeks new authority and more than $29 million in additional fees specifically to improve its postmarket safety surveillance.
An FDA advisory committee is recommending that the agency fundamentally change standards for testing new contraceptives to focus on comparative drug studies.
Although adaptive seamless design (ASD) in clinical trials offers many benefits, "there is no free lunch," said Sue-Jane Wang, associate director at the FDA's Office of Biostatistics.
Adaptive clinical trials make it possible for sponsors to enroll smaller numbers of patients, put a quick stop to treatment approaches that aren’t working and save time and money overall, say experts.