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The Generic Pharmaceutical Association (GPhA) wants the FDA to add regulatory language that would expressly require a brand firm to correct or delete patent information in the agency's Orange Book when a court order requires patent changes.
The political firestorm ignited by the FDA’s decision not to approve OTC status for an emergency oral contraceptive earlier this month could intensify today with the expected introduction of a House bill directing the agency to conduct a formal review of the process it used to make its decision.
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.
Manufacturers of OTC antidiarrheal drugs containing bismuth subsalicylate can include an indication for relief of traveler’s diarrhea in product labeling, according to the FDA.
The FDA should implement an administrative penalty to discourage generic firms from missing deadlines for submitting notifications that start the 45-day clock for drugmakers to file patent-infringement lawsuits, PhRMA said in comments suggesting changes in FDA drug patent rules.
The FDA’s decision last week to reject Barr Pharmaceutical’s bid for OTC status for its Plan B emergency oral contraceptive was based on scientific analysis of the data, and not political pressure from the White House or Congress, according to a top FDA official.
California-based devicemaker Staar Surgical has been taken to task by the FDA for failing to obtain approval before initiating a clinical study that the agency claimed was inadequately administered and supervised.
The FDA has issued a warning letter to Abbott Laboratories following a pair of facility inspections that revealed serious quality system regulation (QSR) violations within its hospital products division, which now operates under the Hospira name.
The FDA envisions the pipeline of combination products moving from the typical current effort to improve the safety, efficacy or ease of use of a drug, device or biologic to a future in which combination products would pursue two or more separate therapeutic benefits.