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Federal policymakers should ensure the FDA has adequate resources in order to review and approve follow-on biologics in a timely and effective manner, according to American Enterprise Institute (AEI) Research Fellow Scott Gottlieb.
Mylan Laboratories lost its bid to launch generic Topamax capsules and tablets after a federal court barred the company from selling its version of the epilepsy treatment prior to late 2008.
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.
GlaxoSmithKline (GSK) could see a boost to sales for its antiviral treatment Relenza following reports of a Japanese Health Ministry recommendation against Tamiflu use in teenagers because of reports of abnormal behavior.
Biotechnology industry leaders are telling House lawmakers that proposed legislation allowing the FDA to approve follow-on biologics should include clear and sound patient safety provisions.
Federal lawmakers should grant adequate funding to the NIH to sustain advances in modern medicine, members of the academic biomedical science and research community said.
Two proposed rules from the FDA strike a "generally reasonable balance" between allowing patient access to investigational drugs and ensuring patient safety, although some changes still need to be made, Public Citizen said.
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.