The Food and Drug Administration is convening its Nonprescription Drugs Advisory Committee Tuesday and Wednesday to debate mandating weight-based dosing for pediatric medicines containing acetaminophen on the Drug Facts label, as well as the potential expansion of dosing instructions to incorporate children under the age of 2 years old, according to material posted online by the FDA on Friday.
A recent Food and Drug Administration inspection prompted the recall of dietary supplements distributed by Multi-Mex Distributor, the company announced Monday. According to an FDA post, the supplements in question bore a close resemblance to antibiotics available in Mexico and may have been confusing to Hispanic consumers.
The Food and Drug Administration will expedite its review of an investigational drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the gastrointestinal tract, the company said Tuesday.
The Food and Drug Administration is moving forward in the creation of a regulatory approval pathway for follow-on biologics and is requesting input from stakeholders and the public, the agency said Monday.
The Food and Drug Administration on Wednesday released the Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products guidance, which outlines how easy-to-use dosage delivery devices and devices that minimize the risk of unintentional overdose can be provided for such over-the-counter medicines as liquid pain relievers, cold medicine, cough syrups and digestion aids.
A major depressive disorder treatment made by Pfizer significantly reduced the number and severity of moderate-to-severe hot flashes in postmenopausal women, compared with placebo, according to a new study.