FDA Policy/General

Latest Federal Register Notices

CDRH 510(k) eSubmission Template Pilot
Federal Register notice: CDRH has announced a voluntary “Electronic Submission Template and Resource (eSTAR) Pilot.” 02/27/2020

Standardized Medicated Feed Assay Limits Guide
Federal Register notice: FDA makes available a draft guidance for industry #264 entitled “Standardized Medicated Feed Assay Limits.” 02/27/2020

Dual 510(k)/CLIA Waiver Guide
Federal Register notice: FDA makes available a final guidance entitled “Recommendations for Dual 510(k) and CLIA Waiver by Application Studies.” 02/26/2020

Guide on Laparoscopic Power Morcellators Labeling
Federal Register notice: FDA makes available a draft guidance entitled “Product Labeling for Laparoscopic Power Morcellators.” 02/26/2020

Guide on CLIA Waiver for IVD Devices
Federal Register notice: FDA makes available a final guidance entitled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” 02/26/2020

Final Guide on Esubmission in eCTD Format
Federal Register notice: FDA makes available a final guidance entitled “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Revision 7).” 02/24/2020

Comments Sought on eCTD Tech Conformance Guide
Federal Register notice: FDA seeks comments on a draft Electronic Common Technical Document v4.0 Technical Conformance Guide and the FDA eCTD v4.0 Module 1 Implementation Package. 02/24/2020

Panel to Review Peanut Allergy Therapy
Federal Register notice: FDA announces a 5/15 Allergenic Products Advisory Committee meeting to review DBV Technologies’ Peanut (Arachis hypogaea) Allergen Extract. 02/24/2020

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