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Senate Finance Committee Chairman Charles Grassley (R-Iowa) is alleging his investigation into allegations the FDA withheld information about a possible link between antidepressant use and suicide in children is being thwarted by FDA managers.
Abbott Laboratories’ promotional materials about the company’s HIV/AIDS drug Norvir are misleading and lacking complete risk information, the FDA’s Division of Drug Marketing, Advertising and Communication (DDMAC) said.
Chlorofluorocarbon (CFC)-propelled albuterol metered dose inhalers (MDIs) should be phased out by 2006, members of the FDA’s Pulmonary-Allergy Drugs Advisory Committee suggested in anticipation of the agency publishing a proposed rule on the matter.
The FDA released a three-part final guidance last week to help manufacturers with the application process for medical imaging drugs and biological products used to diagnose and monitor diseases or conditions.
The FDA has ordered GlaxoSmithKline (GSK) to immediately cease broadcasting a TV advertisement for Paxil CR that suggests the antidepressant is useful for people who do not generally require psychopharmacological treatment.
“Contracting issues” have been delaying the implementation timeline for the new FDA gateway for electronic submissions, said Michael Fauntleroy, program manager at the FDA Gateway program and director of the electronic submissions program at the Center for Biologics Evaluation and Research (CBER).
Generic firms can develop generic biologics using available raw materials, and the FDA can approve the products as fully substitutable for their brand equivalents under current regulations, according to Barr Pharmaceuticals’ executives, who challenged some commonly held perceptions about the complex molecules.
The FDA is looking for ways to increase compliance with a law mandating that companies engaged in clinical trials of drugs for serious or life-threatening diseases post notices about study data on a federal website.