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Domestic and foreign FDA inspections of biologic and drug manufacturing facilities declined in fiscal 2006, from 4,513 in 2005 to 4,237, according to a recent report from the FDA’s Office of Regulatory Affairs.
The FDA needs a more active drug safety surveillance system and more authority over drugmakers when it finds serious adverse events, according to a leading consumer watchdog group.
The FDA has released documents questioning a new prostate cancer drug’s efficacy days before an agency advisory committee meets to discuss the product.
Sen. Chuck Grassley (R-Iowa) said comments from FDA Commissioner Andrew von Eschenbach discourage openness within the agency and raise questions about what problems the agency might be trying to conceal.
Sen. Chuck Grassley (R-Iowa) is asking FDA Commissioner Andrew von Eschenbach to account for the agency’s delays in taking action on updating acetaminophen product labeling to reflect safety issues.
Sens. Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) have asked FDA Commissioner Andrew von Eschenbach to respond to an independent review that called the agency’s postmarketing surveillance system “dysfunctional.”
The FDA is proposing rules in a draft guidance that would bar any person with more than $50,000 in ties to drug and device companies from participating in an agency advisory committee.
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.
The FDA’s Chicago district office and the Society of Clinical Research Associates are sponsoring a workshop on FDA clinical trial statutory and regulatory requirements May 16–17 in Oak Brook, Ill.
While the FDA’s recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) would cover the agency’s needs, Congress should consider appropriating more funds so the agency does not rely so much on user fees, PhRMA CEO Billy Tauzin said.