FDA Policy/General

Latest FDA Warning Letters

Notice Corrected on ANDA Approval Withdrawals
Federal Register notice: FDA corrects a 1/8 Federal Register notice that announced the withdrawal 23 ANDAs. 04/07/2020

User Fee Report on Drug/Biosimilar Review Resources
Federal Register notice: FDA posts a user fee-related report providing options and recommendations for a new methodology to assess changes in the resource and capacity needs for human drug and biosimilar biologic reviews. 04/07/2020

Panel Review of GSK Trelegy Ellipta sNDA Postponed
Federal Register notice: FDA postpones a 4/21-planned Pulmonary-Allergy Drugs Advisory Committee meeting that was scheduled to discuss a GlaxoSmithKline supplemental NDA for Trelegy Ellipta. 04/07/2020

Info Collection on Service Delivery Feedback
Federal Register notice: FDA seeks comments on an information collection extension for “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.” 04/06/2020

Info Collection on Cell, Tissue Product Registration
Federal Register notice: FDA sends to OMB an information collection extension for “Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice.” 04/06/2020

Device User Fee Reauthorization Meeting 5/5
Federal Register notice: FDA reschedules for 5/5 its public meeting entitled “Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027.” 04/06/2020

Info Collection on Dietary Supplement GMPs
Federal Register notice: FDA sends to OMB an information collection revision entitled “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR Part 111.” 04/03/2020

Info Collection on FOIA Identity Certification
Federal Register notice: FDA sends to OMB an information collection extension for “Certification of Identity; Form FDA 3975.” 04/03/2020

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