FDA Policy/General

Latest Federal Register Notices

Draft Guide on Investigator Safety Reporting
9/30/2021 Federal Register notice: FDA has released a draft guidance entitled Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices. The document is intended to help clinical investigators to identify safety information that is considered an unanticipated problem involving risk to human subjects or others and that therefore requires prompt reporting to IRBs. To view the notice, click here.

Draft Guide on Drug Benefit-Risk Assessments
9/30/2021 Federal Register notice: FDA has made available a draft guidance entitled Benefit-Risk Assessment for New Drug and Biological Products. The document is intended to provide drug sponsors and other stakeholders with a clearer understanding about how considerations about a drug’s benefits, risks, and risk management options factor into certain FDA pre- and postmarket regulatory decisions. To view the notice, click here.

Micro Considerations for Non-sterile Drugs
9/30/2021 Federal Register notice: FDA is making available a draft guidance entitled Microbiological Quality Considerations in Non-Sterile Drug Manufacturing. The document discusses product development considerations, risk assessments, and certain GMP requirements that are particularly relevant to microbiological control in a manufacturing operation for such products. To view the notice, click here.

Tropical Disease Review Voucher Fee Rate
9/29/2021 Federal Register notice: FDA has announced the fee rates for using a tropical disease priority review voucher for fiscal year 2022 — $1,266,651. The vouchers are awarded to the sponsors of certain tropical disease product applications submitted after 9/27/2007, upon approval. The notice also outlines the payment procedures for such fees. To view the notice, click here.

Rare Pediatric Disease Priority Voucher Fee
9/29/2021 Federal Register notice: FDA has announced the fee rate for using a rare pediatric disease priority review voucher for fiscal year 2022 — $1,266,651. The notice also outlines the payment procedures for such fees. To view the notice, click here.

Guide on Nontuberculous Mycobacterial Pulmonary Disease
9/28/2021 Federal Register notice: FDA has made available a draft guidance entitled Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment. The document addresses FDA’s current thinking on clinical trial design issues, choice of study population, and endpoints for the treatment of naïve and refractory nontuberculous mycobacterial pulmonary disease caused by Mycobacterium avium complex.

Draft 510(k) eSubmission Template
9/29/2021 Federal Register notice: FDA has made available a draft guidance entitled Electronic Submission Template for Medical Device 510(k) Submissions. The document is part of FDA’s commitment to develop electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. To view the notice, 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

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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