Drugs

FDA Guide on Safety Report e-Submissions

FDA has released a final guidance entitled “Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies.” The document provides instructions for electronically submitting to FDA’s Adverse Event Reporting System (FAERS) expedited individual case safety reports (ICSRs) from IND-exempt bioavailability (BA)/bioequivalence (BE) studies conducted to support ANDAs. The agency says an ICSR captures information necessary to support the reporting of an adverse event related to an individual subject that is associated with the use of an FDA-regulated product, adding that e-submitting ICSRs from IND-exempt BA/BE studies is a new voluntary option.

In the past, expedited safety reports from IND-exempt BA/BE studies have been submitted to the Office of Generic Drugs by email, telephone, or fax using Form FDA 3500A. Recent enhancements to FAERS now enables electronic submissions of such reports. FDA provides two options for electronic submission of ICSRs and ICSR attachments to FAERS:

FAERS database-to-database transmission (“E2B”) submission through the Electronic Submissions Gateway
Submission through the Safety Reporting Portal (SRP)

The agency says submitters will need an account for both options, and the guidance contains instructions for creating these.

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