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.

Hangzhou Karic Commodities Hangzhou, China (7/31): FDA inspected the firm in March 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 a drug product. Additionally, it failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm617355.htm

Kyowa Hakko Bio Yamaguchi, Japan (8/10): FDA inspected the firm 9/2017 and cited significant GMP deviations for active pharmaceutical ingredients (APIs). For example, the firm’s quality unit failed to exercise its responsibility to ensure the API manufactured are in compliance with GMPs. It performed retesting or manipulated data after obtaining out-of-specification or other unacceptable results. The firm also failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failed to have adequate controls to prevent omission of data. Additionally, the agency documented repeat observations that were cited in a previous Warning Letter.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm617419.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