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The FDA has pushed back the timeline for implementing its structured product labeling (SPL) file format requirement, effectively extending the deadline for companies to begin using the new standard when submitting drug-labeling data.
The FDA has issued a new International Conference on Harmonisation guidance containing recommendations for evaluating the stability data needed to propose a retest period for a drug substance and a shelf life for a drug product.
The FDA’s cGMP risk model will be among the topics of discussion at a July meeting of the agency’s Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science.
Tri-Med Laboratories has been cited by the FDA for a slew of cGMP violations at its Somerset, N.J., plant, where it manufacturers cough and cold syrups and other products.
A pair of drugmakers received warning letters from the FDA recently — one for false and misleading claims for an herbal cancer treatment, the other for noncompliance with the postmarketing adverse drug experience (PADE) reporting requirements.
The nation’s second-largest manufacturer of private-label OTC products was recently slapped with an FDA warning letter documenting more than a dozen deviations from cGMP regulations.
Failure to adhere to regulations covering production and process control procedures is the most common observation documented by FDA investigators during pharmaceutical facility inspections, according to an agency analysis of recent Form 483 reports.
An internal review of FDA employee records to determine possible conflicts of interest has not identified any additional approved outside activities of concern, acting FDA Commissioner Lester Crawford announced Friday.
A citizen petition filed last week with the FDA is delaying final approval of a generic version of GlaxoSmithKline’s (GSK’s) profitable allergy nasal spray drug Flonase, generic drug sources said.