The US Food and Drug Administration (FDA) is laying the groundwork to eventually transition away from the use of paper-based inspection journals in favor of digital-based tablet inspection aids, say several FDA officials. The agency, including FDA Commissioner Margaret Hamburg, has recently begun to tout its use of a new, Windows-based rugged tablet computer for use during egg  farm inspections. An FDA spokeswoman, Patricia El-Hinnawy, told Regulatory Focus that ...

In the long list of things that are inadvisable to regulatory professionals, making misleading statements to the authority in charge of regulating your business likely ranks near the top. Those found to have misled the US Food and Drug Administration (FDA) have in the past been publicly warned, fined, imprisoned, shut down and barred from participating in federal programs. Now KV Pharmaceuticals is facing the prospect of an additional action: a class-action shareholder l...

The US Food and Drug Administration (FDA) fired off numerous warning letters to dietary supplement manufacturers this week. While its actions against ten manufacturers of dimethylamylamine (DMAA) garnered significant attention , FDA also sent warning letters to six other dietary supplement manufacturers for allegedly violating numerous regulations under the Federal Food, Drug and Cosmetic Act (FDCA) . Manufacturer Vitality Distributing, Inc.,  received an FDA warn...

A warning letter sent to the company Young Medical Spa by the US Food and Drug Administration (FDA) cites the company for violating minimal manipulation regulations governing the use of human cells, tissues or cellular and tissue-based products (HCT/Ps). FDA's warning letter specifically cites Young's Owner and Medical Director Thomas E. Young for removing, reprocessing and injecting patients with their own adipose tissue (lipoaspirate), from which Young isolated stem ce...