FDA Policy/General

Latest Federal Register Notices

Blood Establishment Software Put Into Class 2
Federal Register final rule: FDA classifies blood establishment computer software and accessories (regulated under product code MMH) into Class 2 (special controls). 05/18/2018

Panel to Review PneumRx PMA for Elevair Endobronchial Coil System
Federal Register notice: FDA announces a 6/14 Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee meeting to review a PneumRx PMA for the PneumRx Elevair Endobronchial Coil System. 05/17/2018

OMB Approves 6 Info Collection Requests
Federal Register notice: FDA posts a list of recent information collections that have been approved by OMB. 05/16/2018

Blood Products Panel to Meet in July
Federal Register notice: FDA announces a 7/18-19 Blood Products Advisory Committee. 05/16/2018

Proposed Rule to Update Combo Product Regulations
Federal Register proposed rule: FDA proposes to amend its regulations concerning the classification of products as biologics, devices, drugs, or combination products, and their assignment to agency components for premarket review and regulation. 05/15/2018

Public Meeting on Chronic Pain Patient Input
Federal Register notice: FDA announces a 7/9 public meeting on “Patient-Focused Drug Development for Chronic Pain” that is intended to provide patients with an opportunity to present their perspectives on the impacts of chronic pain. 05/15/2018

Pediatric Oncology Drugs Advisory Committee Meeting 6/20
Federal Register notice: FDA announces a Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting 6/20 to review and discuss a list of molecular targets for product development. 05/15/2018

Draft Guide on Pediatric HIV Studies
Federal Register notice: FDA makes available a draft entitled “Pediatric HIV Infection: Drug Development for Treatment.” 05/14/2018

Info Collection on Drug Supply Chain Security Pilot
Federal Register notice: FDA submits for OMB approval a new proposed information collection entitled “DSCSA Pilot Project Program.” 05/14/2018

FDA Partial Withdrawal of OTC Monograph
Federal Register notice: FDA announces a partial withdrawal of a proposed rule published in the 8/21/2003 Federal Register that would have amended the agency’s tentative final monograph for over-the-counter internal analgesic, antipyretic, and antirheumatic drug products to include ibuprofen as generally recognized as safe and effective. 05/14/2018

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