FDA Policy/General

Latest Federal Register Notices

Panel to Review Jardiance sNDA
Federal Register notice: FDA announces an 11/13 Endocrinologic and Metabolic Drugs Advisory Committee meeting to review a Boehringer Ingelheim supplemental NDA for Jardiance. 10/04/2019

Clinical Data Standards Pilot: Correction
Federal Register notice: FDA corrects a notice that appeared in 8/20 Federal Register announcing a “Fit for Use Pilot Program Invitation for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide.” 10/04/2019

Guide on Enzyme Replacement Therapy Products
Federal Register notice: FDA makes available a final guidance entitled “Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment.” 10/03/2019

Fed Reg Notice on Pemoline Corrected
Federal Register notice: FDA corrects a 6/4 Federal Register notice withdrawing approval of five ANDAs for pemoline products because it contained an incorrect Web site address for an archived drug safety notice. 10/03/2019

24 Drugs not Withdrawn Due to Safety/Efficacy: FDA
Federal Register notice: FDA determines that 24 drug products were not withdrawn due to safety or effectiveness reasons. 10/01/2019

Panel Mulls Immune Responses with Metal Devices
Federal Register notice: FDA announces an 11/13-14 Immunology Devices Panel of the Medical Devices Advisory Committee meeting to discuss immunological responses to metal-containing medical devices. 10/01/2019

Draft Guide on Patient-focused Drug Development
Federal Register notice: FDA makes available a draft guidance on “Patient-Focused Drug Development: Methods To Identify What Is Important to Patients.” 10/01/2019

Fee for Tropical Disease Priority Review Voucher
Federal Register notice: FDA announces the fee rate of $2,167,116 for using a tropical disease priority review voucher for fiscal year 2020. 09/30/2019

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