Today, FDA released Draft Guidance for Industry: Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality Considerations. This draft guidance describes the Agency’s recommendations […]

[10/4/2018] The Food and Drug Administration is alerting consumers and pet owners about a voluntary recall of certain lots of eight products – six products for […]

[10/11/2018] The Food and Drug Administration is alerting consumers about a voluntary recall of all lots with expiration dates from October 2018 to July 2022 of […]

[11/2/2018] FDA is alerting patients, caregivers and health care professionals that the labels attached to some EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized […]

Compounded drugs were produced under poor sterile production practices in an inadequately designed processing room [12/7/2018] The U.S. Food and Drug Administration is alerting health care […]

[12/11/2018] The U.S. Food and Drug Administration is alerting consumers, particularly males, not to purchase or use two e-liquids sold by HelloCig Electronic Technology Co. Ltd. […]

Update [3/29/19] FDA is alerting health care professionals and patients of McDaniel Life-Line’s voluntarily recall of all lots of Life-Line Water. This product is being recalled […]

[6/21/2019] The U.S. Food and Drug Administration is alerting healthcare professionals and patients of a voluntary recall of all unexpired compounded drugs intended to be sterile […]

[6/25/2019] FDA is warning consumers not to use products marketed by Kratom NC, of Wilmington, North Carolina, due to microbial contamination. FDA laboratory analysis of Kratom […]