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The FDA issued letters to manufacturers of all attention-deficit/hyperactivity disorder (ADHD) products asking them to implement new medication guides, saying it is concerned about cardiovascular risks and adverse psychiatric symptoms.
A pathway for creating and marketing generic biologics could help health plan sponsors and patients save $71 billion over the next 10 years, according to an Express Scripts report.
Recommendations in the latest installment of the Prescription Drug User Fee Act (PDUFA) seek to bulk up the premarket drug approval process, stabilize financing and expedite drug development, FDA officials said at a recent public hearing.
Several recent FDA warning letters focus on violations by clinical investigators, ranging from informed consent failures to not getting required approvals and enrolling ineligible subjects.
Members of the House Committee on Energy and Commerce requested more information from the FDA regarding its approval of the antibiotic Ketek following a subcommittee hearing on the agency’s drug approval process.
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 FDA warned Abraxis Bioscience for distributing pharmaceuticals that could have been contaminated during manufacture and for marketing drugs without approved new drug applications.
Amgen is facing more bad news regarding possible off-label uses of its drug Aranesp after independent study results pointed to adverse outcomes for a certain class of cancer patients prescribed the drug.
Americans who attempted to purchase certain drugs over the internet instead received products containing haloperidol, a strong anti-psychotic drug, the FDA said.