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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 FDA has accused a California devicemaker of widespread violations of good manufacturing practices (GMP) and quality system (QS) regulations at its Huntington Beach facility.
The FDA has reclassified two types of dental implants from Class III to Class II to lessen the regulatory burden on devicemakers, according to a final rule and draft guidance published May 11.
The FDA issued a final rule May 10 designating the immunomagnetic circulating cancer cell (CCC) selection and enumeration system as a Class II device with special controls.
The U.S. Patent and Trademark Office (PTO) wants to let third parties – including generic drugmakers — challenge the validity of new patents before PTO administrative law judges, thus avoiding the need to battle patents later in federal courts.
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 chairman of the Senate Finance Committee has asked the FDA to provide him with detailed information about its contract with Columbia University to evaluate reported adverse events as part of his ongoing investigation into allegations that the agency withheld information about a possible link between child suicide and antidepressant use.
The FDA was not bowing to political pressure in its recent decision to reject Barr Pharmaceutical’s bid for OTC status for its Plan B emergency oral contraceptive, but rather the agency’s decision was based on the best scientific analysis of the available data, according to a top FDA official.
The FDA should implement an administrative penalty to discourage generic drug 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.