FDA Policy/General

Latest Federal Register Notices

Covid-19 Guidance Documents Listing
4/23/2021 Federal Register notice: FDA is updating the availability of guidance documents related to the Covid-19 public health emergency. The listing is periodically being updated as part of the agency’s transparency efforts during the health emergency. The documents have been implemented without prior comment, but they remain subject to comment in accordance with FDA’s good guidance practices. To view the notice, click here.

Workshop on Model Informed Drug Development
4/22/2021 Federal Register notice: FDA is announcing a 6/9 public workshop entitled “Model Informed Drug Development Approaches for Immunogenicity Assessments.” The workshop will discuss the best practices and future directions of quantitative methods for predicting biological product immunogenicity. It is also being conducted to satisfy one of FDA’s performance goals under the Prescription Drug User Fee Amendments related to model-informed drug development. To view the notice, click here.

EUA Listing for Covid Molecular/Antigen Tests
4/22/2021 Federal Register notice: FDA has published an updated listing of Emergency Use Authorizations (EUAs) for molecular diagnostic and antigen tests for Covid-19, excluding multi-analyte tests. The EUAs contain, among other things, conditions for their emergency use. To view the notice, click here.

Info Collection on Soy Protein Health Claim
4/22/2021 Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim — 21 CFR 101.82” (OMB Control Number 0910-0428). 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