FDA Policy/General

FDA Posts 10 OMB Comment Request Notices

Federal Register Notices: FDA has posted 10 Office of Management and Budget information collection notices, nine of them health product-focused, that have been backlogged and now released after a regulatory review by the Trump administration. The nine are:

Comment Request: Testing Communications on Medical Devices and Radiation-Emitting Products. To view the notice, click here.
Comment Request: Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use. To view the notice, click here.
Comment Request: Food and Drug Administration Safety Communication Readership Survey. To view the notice, click here.
Comment Request: Focus Groups About Drug Products as Used by the Food and Drug Administration. To view the notice, click here.
Comment Request: Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics. To view the notice, click here.
Comment Request: Safety Assurance Case. In 2011, FDA announced its intention to evaluate the use of assurance cases as part of its Plan of Action to strengthen the 510(k) program following the publication of a draft guidance on infusion pumps. To view the notice, click here.
Comment Request: Guidance for Industry on Special Protocol Assessment. To view the notice, click here.
Comment Request: Guidance for Industry on Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products. To view the notice, click here.
Comment Request: Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure. To view the notice, click here.

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