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.

Degasa S.A. De C.V. México City, México (4/18): FDA inspected the firm’s drug manufacturing facility 9/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm does not perform appropriate laboratory testing of each batch of drug product. The firm also failed to ensure that laboratory records include complete data derived from all tests necessary to assure compliance with established specifications and standards.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm605390.htm

Lijiang Yinghua Biochemical and Pharmaceutical Co. Lijiang, China (4/19): FDA inspected the firm 10/2017 and cited it for GMP deficiencies for active pharmaceutical ingredients (APIs). For example, the firm failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data. It also failed to maintain complete data derived from all laboratory tests conducted to ensure its APIs and intermediates comply with established specifications and standards. FDA recommended that the company retain a consultant to assist in correcting its quality system to ensure the accuracy and integrity of data.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm605392.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