FDA Policy/General

Latest Federal Register Notices

24 ANDA Approvals Withdrawn
Federal Register notice: FDA withdraws approval of 24 ANDAs from multiple applicants because the products are no longer marketed. 02/23/2018

Regulatory Review Period Determined for Zydelig
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for ICOS Corp.'s Zydelig (idelalisib) is 2,247 days. 02/23/2018

FDA Panel Meeting to Review Device Reclassifications
Federal Register notice: FDA announcesa 3/21-22 joint meeting of its Blood Products Advisory Committee and the Microbiology Devices Panel of the Medical Devices Advisory Committee to review two device reclassifications. 02/22/2018

Medical Device Labeling Information Collection Extension
Federal Register notice: FDA seeks comments on an information collection exetension for “Medical Device Labeling Regulations — 21 CFR parts 800, 801, and 809” (OMB Control Number 0910-0485). 02/22/2018

Panel to Review Cannabidiol NDA
Federal Register notice: FDA announces a 4/19 Peripheral and Central Nervous System Drugs Advisory Committee meeting. 02/22/2018

Final Rule on Device Trials Conducted Outside U.S.
Federal Register final rule: FDA amends its regulations on data acceptance from clinical investigations for medical devices conducted outside the U.S. to support a device submission to require that such studies be conducted in accordance with good clinical practice. 02/21/2018

Regulatory Review Period Determined for Darzalex
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Genmab’s Darzalex (daratumumab) is 1,939 days. 02/20/2018

Regulatory Review Period Determined for Portrazza
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Eli Lilly’s Portrazza (necitumumab) is 2,533 days. 02/20/2018

Laboratory Reorganization Under FDA Program Alignment
Federal Register notice: FDA announces that its Office of Global Regulatory Operations and Policy, Office of Regulatory Affairs, and Office of Regulatory Science have been restructured 6/2016 under its Program Alignment Initiative. 02/20/2018

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