FDA Policy/General

Warning Letters Released 7/3/2018

FDA 7/3 posted the latest batch of Warning Letters while FDA Webview was closed for its annual holiday break. They can be accessed by clicking on the link following each letter.

Foshan Jinxiong Technology Foshan City, China (6/26): FDA inspected the firm 8/2017 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 for the drug product. The firm also failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm612483.htm

Sichuan Friendly Pharmaceutical Co. Neijiang City, China (6/22): FDA inspected the firm 10/2018 and cited significant GMP deviations for active pharmaceutical ingredients. For example, the firm failed to ensure that all specifications and test procedures are scientifically sound and appropriate to ensure that APIs conform to established standards of quality and purity. Additionally, the firm failed to adequately validate written procedures for the cleaning and maintenance of equipment.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm612389.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