Drugs

Some Adverse Event Reporting Relaxed Under Pandemic

FDA has issued a guidance entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic.” The document discusses situations where medical product adverse event reports could be delayed due to pandemic-related high employee absenteeism. The document says that certain required submissions could be delayed provided that they are submitted within six months of the restoration of reporting processes to their pre-pandemic state. Firms should maintain records to identify what has been stored and when the processes were restored, it says. The guidance does not apply to adverse event reporting by firms that are able to continue reporting operations.

FDA intends to communicate with firms if there are products and issues that present special concerns and for which the agency expects compliance with normal reporting as required by statute and regulation during the pandemic. Special concerns, the agency says, could include:

product-related safety issues such as (but not limited to) newly emerging safety issues (e.g., an antihypertensive drug associated with liver failure or a non-pandemic-related vaccine associated with anaphylaxis)
product problems with associated adverse events (e.g., nonfatal serious infections associated with a pre-filled syringe that was recalled due to bacterial contamination)

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