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GlaxoSmithKline (GSK) has strengthened the warning labels on two of its antidepressant drugs -- a move that follows an FDA public health advisory in March that recommended closer monitoring of patients being treated with antidepressants.
Authorized generics are legal under FDA regulations and any move to keep them off the market until another generic firm’s 180-day exclusivity period expires would violate federal drug law, argues brand firm Johnson & Johnson (J&J).
Sen. Hillary Clinton (D-N.Y.) has joined the chorus of federal lawmakers seeking more detail about the rationale behind the FDA’s decision last month to deny OTC status for Barr Pharmaceutical’s Plan B emergency oral contraceptive.
The FDA should move forward and approve generic versions of McNeil Consumer & Specialty Pharmaceuticals’ attention deficit/hyperactivity disorder drug Concerta, argues a law firm in response to a McNeil citizen petition that has delayed generic entry.
Two House committee chairmen Friday asked that 15 federal agencies -- including the HHS, the FDA and the FTC -- reveal the extent of awards, contracts and other agreements between their employees and outside interests.
The FDA’s Dispute Resolution Panel is an effective tool for firms that disagree with decisions made by the Center for Devices and Radiological Health (CDRH), but it should be considered a last resort due to the time and financial resources it takes to see an appeal come to fruition, according to CDRH Ombudsman Les Weinstein, who spoke June 14 at the Medical Device & Manufacturing meeting in New York City.
The FDA is mulling various options to increase compliance with a law mandating that companies engaged in clinical trials of drugs or medical devices intended to treat serious or life-threatening diseases post notices about study data on a federal website.
The FDA last week announced that its Circulatory System Devices Panel will review next month Guidant’s submission to expand user labeling, including indications, for its cardiac resynchronization therapy (CRT) defibrillators.
Despite objections from some panel members, an FDA advisory panel voted last week to recommend approval for Cyberonics’ nerve stimulation implant as a treatment for chronic depression.
The FDA should issue regulations that would eliminate a brand company’s ability to license an authorized generic product until the first generic applicant’s 180-day exclusivity period has expired, the Generic Pharmaceutical Association (GPhA) has told the agency.