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.

New Capstone Kihei, HI (6/27): FDA reviewed the firm’s Web site (www.rnareset.com) in May and determined that its products (ReMyte, ReAline, ReMag, ReStructure, and ReCalcia Pico Meter Calcium) are new drugs based on claims and personal testimonials on the Web site. The agency further determined that the products are intended for treating one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm565851.htm

Vista Pharmaceuticals Limited Hyderabad, India (7/5): FDA inspected the firm’s drug manufacturing facility and cited significant GMP violations with its finished pharmaceuticals. For example, the firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination. FDA said a product complaint about metal embedded in one of the company’s tablets was not investigated adequately because it failed to consider whether the poor equipment condition may have contributed to the problem. Additionally, the firm admitted to FDA investigators that it had not performed process validation for isoxsuprine hydrochloride 20 mg tablets despite distributing the products to the U.S. from 2014 to 2016.

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm565861.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