Drugs

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.

Adolfo E. Kaplan, Pulmonary and Sleep Center of the Valley McAllen, Texas (4/20) FDA inspected the clinical investigator’s site 11/2016 and it observed objectionable conditions associated with the conduct of clinical investigations and the protection of human subjects. For example, the investigator failed to ensure that the investigation was conducted according to the investigational plan. The investigator also did not adhere to the eligibility criteria as specified in the protocol.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm564172.htm

Raritan Pharmaceuticals East Brunswick, NJ (6/20): FDA inspected the company’s drug manufacturing facility 10/2016 and cited the firm for significant GMP violations. For example, the firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. The firm also was found to not have adequate written procedures for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality and purity they purport to possess.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm564194.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

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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