FDA Policy/General

Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Biologique Recherche Suresnes, France (6/8): FDA inspected the firm 9/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications. The firm also failed to conduct at least one test to verify the identity of each component of its drug product. And, it failed to establish written responsibilities and procedures applicable to the quality control unit.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm610849.htm

Oeyama-Moto Medical Group Foundation West Covina, CA (5/21): FDA inspected the medical group 8/2017 and cited objectionable conditions regarding nonclinical laboratory studies of an investigational drug. For example, the testing facility management failed to assure that there was a quality assurance unit that was responsible for monitoring each study and was entirely separate from and independent of the personnel engaged in the conduct of the studies. Additionally, the testing facility failed to establish standard operating procedures in writing that outlined laboratory study methods that are adequate to ensure the quality and integrity of the data generated in the course of the studies.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm610919.htm

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome