FDA Policy/General

Latest Federal Register Notices

Notice on Pathogen Reduction Workshop Corrected
Federal Register notice: FDA corrects a 9/17 notice announcing an 11/29 public workshop entitled “Pathogen Reduction Technologies for Blood Safety.” 10/12/2018

FDA Renews Dermatologic/Ophthalmic Drugs Panel Charter
Federal Register notice: FDA renews the charter of its Dermatologic and Ophthalmic Drugs Advisory Committee for an additional two years. 10/11/2018

FDA Renews Charter for Antimicrobial Drugs Panel
Federal Register notice: FDA renews for two years the charter of its Antimicrobial Drugs Advisory Committee. 10/11/2018

Draft Guide on Transdermal Irritation Studies
Federal Register notice: FDA makes available a draft guidance entitled “Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.” 10/10/2018

List of Information Collections Approved by OMB
Federal Register notice: FDA publishes a list of information collections that have been recently approved by OMB. 10/10/2018

Draft Guide on Drug Patch Adhesion Studies
Federal Register notice: FDA makes available a revised draft guidance entitled “Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs.” 10/10/2018

Comments Sought on WHO Drug Scheduling for 16 Drugs
Federal Register notice: FDA requests comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for 16 drug substances. 10/09/2018

25 New and Revised ANDA Bioequivalence Draft Guides
Federal Register notice: FDA makes available two new product-specific draft guidances for submitting ANDAs for capsaicin and estradiol (norethindrone acetate), in addition to 23 other revised guidances. 10/09/2018

Panel to Discuss Opioid Analgesic Sparing Outcomes
Federal Register notice: FDA announces an 11/15 Anesthetic and Analgesic Drug Products Advisory Committee meeting to discuss the assessment of opioid analgesic sparing outcomes in acute pain clinical trials. 10/08/2018

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