FDA Policy/General

Latest Federal Register Notices

Guide on Product-specific Bioequivalence
7/16/2021 Federal Register notice: FDA has made available a draft guidance entitled “Draft Guidance for Cilastatin Sodium; Imipenem; Relebactam.” The document provides product-specific recommendations on the bioequivalence study designs to support ANDA submissions for such products. To view the notice, click here.

Proposed Study of Medical Conference Drug Promotions
7/16/2021 Federal Register notice: FDA has submitted to OMB a proposed information collection entitled “Medical Conference Attendees’ Observations About Prescription Drug Promotion.” The study is intended to focus on understanding the landscape of healthcare provider-directed promotion of prescription drugs at medical conferences in general. More specifically, it will examine elements of pharmaceutical booths in medical conference exhibit halls and the impact on attendees’ perceptions of the drugs that are promoted at those booths. To view the notice, click here.

Stromectol Not Withdrawn Due to Safety/Efficacy
7/14/2021 Federal Register notice: FDA has determined that Merck’s Stromectol (ivermectin) tablets, 6 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. The product is indicated for strongyloidiasis of the intestinal tract and onchocerciasis. To view the notice, click here.

Guide on Animal Drug Conditional Approval
7/13/2021 Federal Register notice: FDA has made available a final guidance entitled Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs. The document notes that eligibility for conditional approval has been expanded beyond minor uses in major species and use in minor species to include certain major uses in major species. To view the notice, click here.

Info Collection on Device Labeling Regs
7/13/2021 Federal Register notice: FDA is seeking comments on an information collection extension entitled “Medical Device Labeling Regulations” (OMB Control No. 0910-0485). The collection supports implementation of medical device labeling requirements governed by section 502 of the Federal Food, Drug, and Cosmetic Act. FDA says the revision was made to include reference to agency guidance. 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