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The FDA cautioned manufacturers and consumers that a collection of supplements are illegally marketed drugs containing so-called designer steroids, issuing three warning letters to Flex Fitness/Big Dan’s Fitness, AndroPharm and Hardcore Formulations. Read More
The FDA is changing its labeling requirements for injectable drug products that contain a single active ingredient — swapping ratios of strength with amounts per unit of volume — in an effort to reduce dosage confusion and related adverse outcomes. Read More
An FDA pediatric cancer advisory panel called on multiple sponsors to continue refining their cancer drugs to adapt them for safe and effective use in pediatric populations. Read More
The FDA has broadened its import ban against Indian manufacturer Ipca Laboratories to include four drugs previously exempted due to shortage. Only Ipca’s anti-malarial API remains exempted and can be imported into the U.S. Read More
FDA Commissioner Scott Gottlieb outlined an action plan to remove barriers to generic competition, saying agency regulations have been “gamed” by brand-name manufacturers to delay generic drug approvals even after patents and exclusivity periods lapse. Read More