We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Janssen Pharmaceutica, a subsidiary of Johnson & Johnson, has been cited by the FDA for false and misleading claims made in promotional materials for its Duragesic pain patch.
The FDA has been unable to reach a final decision on whether to approve generic firm Sandoz’s application to market Omnitrope, a follow-on version of Pfizer’s human growth hormone biologic, Genotropin.
An FDA proposed rule requiring that the labeling of Rx drugs and some OTC drugs include a toll-free number for consumers to report adverse events could jeopardize the integrity of the MedWatch program, according to a major brand firm.
Some drugmakers may decide not to disseminate useful disease awareness communications if the FDA finalizes a draft proposal that says help-seeking messages must be perceptually distinct from specific drug ads or face agency rules governing advertising, Pfizer said.
Drugmaker Dey wants the FDA to provide a written determination that it is entitled to a 30-month stay after suing generic firm Ivax over its patent challenge to Dey’s inhalation lung disease treatment DuoNeb.
Vintage Pharmaceuticals has been issued a warning letter from the FDA for failing to comply with postmarketing adverse drug experience (ADE) reporting requirements of the Federal Food, Drug and Cosmetic Act.
The city of New York has filed a complaint against 44 pharmaceutical firms and their subsidiaries for a series of alleged fraud violations that resulted in millions of dollars of overcharges to the city’s Medicaid budget
Current and former FDA officials, as well as Republican lawmakers, are defending the FDA’s Office of Chief Counsel (OCC), asserting that the agency is empowered by federal law to intervene on behalf of drugmakers in consumer lawsuits and asking that the office not be penalized for doing so.
A provision passed by the House barring the FDA from spending federal money to block the importation of Rx drugs potentially could pave the way for counterfeiters to flood the U.S. market with fake products, according to the agency’s director of pharmacy affairs.
The FDA has issued warning letters to two companies for unapproved marketing claims for topical creams as treatments for sexually transmitted diseases (STDs), bacterial infections and the common cold.