Drug – FDA Compliance Made Easy

FDA Warning Issued to Fraudulent and Unapproved Flu Products

Disease Claims, Drug, Drugs, Enforcement, FDA, fda warning, Guidance, Labeling, Warning LettersFDA

On March 2, 2018, the U.S. Food & Drug Administration (“FDA”) published a warning to the public entitled “FDA warns of fraudulent and unapproved flu products (“FDA Warning”). Found here, the FDA Warning is aimed at notifying the public of …

FDA Warns of Marketing Cosmetics with Drug Claims

Cosmetics, Disease Claims, Drug, Drugs, Enforcement, FDA, Labeling, Structure-Function Claims, Warning LettersFDA

The difference between a product being marketed as a cosmetic and marketed as a drug can be a very thin line. However, the differences in regulation between the two are stark. The Federal Food Drug and Cosmetic Act (The Act) …

FDA Approval Required for Company Enjoined from Marketing Products

Disease Claims, Drug, Drugs, Enforcement, FDA, FDA Approval, Injunction, Labeling, Marshalls, NDA, SeizureFDA

On October 10, 2014, a federal judge from the U.S. District Court for the Southern District of Ohio sided with the U.S. Food & Drug Administration (“FDA”) and entered a consent decree for permanent injunction against Ascend Laboratories, LLC. As …

FDA Seeks Injunction against Company for Misbranding Drug Products

Disease Claims, Drug, Drugs, Enforcement, FDA, Labeling, Warning LettersFDA

On June 25, 2014, the U.S. Department of Justice (“DOJ”), in response to a request made by the U.S. Food and Drug Administration (“FDA”), filed a complaint seeking a permanent injunction against Laclede, Inc. of Rancho Domingo California and the …

FDA Seizes Topical Creams Deemed Drugs

Disease Claims, Drug, Drugs, Enforcement, Labeling, NDAFDA

On May 16, 2014, the U.S. Food and Drug Administration (“FDA”), with assistance by the U.S. Attorney for the Southern District of Ohio, seized unapproved drugs valued at more than $11 million, which were marked by Ascend Laboratories of Montvale, …

FDA Approves First Drug Specifically Formulated to Treat Pediatric Tumors

Accelerated Approval Program, Drug, Drugs, FDA, Pediatric, post-marketing studiesFDA

On August 29, 2012, the U.S. Food and Drug Administration (“FDA”) announced the Agency’s approval of a new drug formulated specifically to treat children with a rare type of brain tumor, known as subependymal giant cell astrocytoma (SEGA). Manufactured by …

FDA Notifies Consumers of Supplement Recall after Discovery of Undeclared Drug Ingredients

Dietary Supplements, Drug, Drugs, FDA, RecallsFDA

On May 18, 2012, the U.S. Food and Drug Administration (“FDA”) published a press release announcing the voluntary recall of certain dietary supplements marketed as male enhancements. West Coast Nutritionals, Ltd., the firm responsible for the supplements, initiated the recall …