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…

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 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. Source: Drug Industry…

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…

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…