Drugs

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.

PRL, Inc. Lobelville, TN (6/6): FDA inspected the firm 10/2018 and cited multiple serious GMP violations for dietary supplements. The letter also says the agency collected labels for the firm’s dietary supplements and a review of the labels and the PRL Web site shows serious violations of the Federal Food, Drug, and Cosmetics Act and applicable regulations. GMP violations include failing to establish product specifications for each dietary supplement, failing to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, and failing to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient before use in manufacturing. To view the letter, click here.

Tropical Seas, Holly Hill, FL (5/15): FDA inspected the firm 5/2018 and found significant GMP violations for finished pharmaceuticals. Specific GMP violations were failing to establish laboratory controls that include scientifically sound and appropriate specifications, and failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. To view the letter, click here.

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

Read more

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