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.

Hanlim Pharm Co. Seocho-Dong, South Korea (10/3): FDA inspected the firm in February and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. The firm also failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm622860.htm

Ignatius P. Godoy Paramount, CA (10/1): FDA inspected the clinical investigator in June and cited clinical study violations associated with a trial involving a Quadrivalent Inactivated Influenza Virus Vaccine. For example, the clinical investigator failed to obtain the legally effective informed consent of a subject’s legally authorized representative prior to involving them in research. The investigator also failed to ensure that the investigation was conducted according to the signed investigator statement, the investigational plan, and applicable regulations.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm623054.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