FDA Policy/General

Latest Federal Register Notices

EUA for Abbott’s BinaxNow Revoked
3/18/2022 Federal Register notice: FDA has revoked an Emergency Use Authorization (EUA) issued to Abbott Diagnostics Scarborough for the BinaxNOW Covid-19 Ag Card 2 Home Test. FDA says Abbott never marketed the test under the EUA, and the product is subsequently marketed and covered by a subsequent EUA. To view the notice, click here.

Info Collection on User Fee Program Evaluation
3/18/2022 Federal Register notice: FDA is seeking comments on an information collection extension entitled “Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original 351(a) Biologics License Applications in Prescription Drug User Fee Acts and 351(k) Biologics License Applications in Biosimilar User Fee Acts” (OMB Control Number 0910-0746). The collection is intended to support the evaluation of certain performance goals and procedures set forth in what is known as FDA’s “goals letter” or “commitment letter” under the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI) and the second authorization of the Biosimilar User Fee Act (BsUFA II). To view the notice, click here.

Comments Sought on Pharma Quality/CMC Data Exchange
3/17/2022 Federal Register notice: FDA is seeking comments on its draft “Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange” for electronically submitting PQ/CMC data. The document provides a draft design of Health Level 7 (HL7) “Fast Health Interoperability Resources” (FHIR) profiles that contain the data elements and terminologies associated with submission. The agency says it cover only those concepts that are considered amenable to structuring and would bring value to the quality review process. The agency says it is seeking comment on the mapping of the PQ/CMC data elements to the various FHIR Resources. To view the notice, click here.

Medwatch Information Collection Revised on eSubmissions
3/15/2022 Federal Register notice: FDA has submitted to OMB and information collection revision entitled “MedWatch: The FDA Safety Information and Adverse Event Reporting Program” (OMB Control Number 0910-0291). The agency is revising the collection to include electronic submission of adverse event reports. To view the notice, click here.

Guide on CAR T Cell Product Development
3/15/2022 Federal Register notice: FDA has made available a draft guidance entitled “Considerations for the Development of Chimeric Antigen Receptor T Cell Products.” The document includes CAR T cell-specific recommendations regarding chemistry, manufacturing, and control, pharmacology and toxicology, and clinical study design. 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