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The biologic license application (BLA) for GlaxoSmithKline’s (GSK) cervical cancer vaccine Cervarix includes efficacy data on a wide range of human papillomavirus HPV vaccine strains, including 16, 18, 31 and 45.
The FDA told RyMed Technologies during a March meeting that the firm’s initial response to a Form 483 regarding alleged current good manufacturing practice violations satisfied the agency’s concerns, according to the firm.
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.
Federal policymakers should ensure the FDA has adequate resources to review and approve follow-on biologics in a timely and effective manner, according to American Enterprise Institute (AEI) Research Fellow Scott Gottlieb.
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.
The FDA has released documents questioning a new prostate cancer drug’s efficacy days before an agency advisory committee meets to discuss the product.
The FDA has sent Congress its final recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA),
including an increase in user fees to pay for drug safety reviews, as well as reviews of direct-to-consumer (DTC) advertising.
Dermatology patients should avoid purchasing Roche’s Accutane or its generic equivalents over the internet, according to safety warnings on a new FDA website detailing the dangers of buying the drug online.