FDA Policy/General

Latest FDA Warning Letters

Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

DSE Healthcare Solutions Edison, New Jersey (3/16): FDA inspected the firm 8/2016 and documented significant GMP violations related to dietary supplements. The agency also cited the firm based on a review of product labels and Web site content. FDA said that therapeutic claims on product labels and Web sites establish that certain products are considered drugs.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm547639.htm

Northwestern University Feinberg School of Medicine Chicago, IL (11/15/2016): FDA 7/2016 conducted a bioresearch monitoring inspection of studies under the direction of clinical investigator Richard Burt. The agency determined that Burt violated regulations governing the proper conduct of clinical studies involving investigational new drugs. For example, FDA said he failed to fulfill the general responsibilities of sponsors and to ensure that investigations are conducted in accordance with the general investigational plan and protocols contained in the IND. FDA also said Burt failed to submit a protocol amendment to the agency when there was a significant change in the protocol design.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm548176.htm

Opto-Pharm Pte Ltd. Republic of Singapore (3/16): FDA inspected the firm’s drug manufacturing facility and cited it for GMP violations associated with finished pharmaceuticals. For example, the firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. The firm failed to establish the reliability of a container-closure supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm547904.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