FDA Policy/General

Latest Federal Register Notices

2 Device Guides on Performance Criteria
04/08/2022 Federal Register notice: FDA has made available two guidance documents for the Safety and Performance Based Pathway. The first is entitled “Surgical Sutures — Performance Criteria for Safety and Performance Based Pathway” and the other is “Orthopedic Fracture Fixation Plates — Performance Criteria for Safety and Performance Based Pathway.” To view the notice, click here.

Final Guide on ICH Drug Study Considerations
04/08/2022 Federal Register notice: FDA is making available a final guidance entitled “E8(R1) General Considerations for Clinical Studies.” The International Council for Harmonization document describes internationally accepted principles and practices for the design and conduct of drug/biologic clinical studies. It also provides an overview of the types of clinical studies that may be performed and data sources used during the product’s lifecycle. To view the notice, click here.

Guide on Hepatitis B Infection Drugs
04/07/2022 Federal Register notice: FDA has made available a final guidance entitled “Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment” that provides general recommendations on the clinical development of such products. It includes general considerations for nonclinical toxicology and virology studies, early phase clinical development, clinical pharmacology assessments, and Phase 3 safety and efficacy trials. It also addresses Phase 3 trial design considerations and efficacy endpoints for the development of finite duration therapies for treating chronic infection. To view the notice, click here.

Public Meeting on Device User Fee Reauthorization
04/06/2022 Federal Register notice: FDA is announcing a 4/19 virtual public meeting entitled “Medical Device User Fee Amendments” to discuss proposed recommendations for the Medical Device User Fee Amendments reauthorization for fiscal years 2023 through 2027. The meeting is intended to give the public an opportunity to present its views on the recommendations. FDA says it will then consider the public input and revise the recommendations as necessary. 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