FDA Policy/General

Latest Federal Register Notices

FDA Information Collections Approved by OMB
Federal Register notice: FDA posts a list of information collections that have been approved by the Office of Management and Budget.
05/26/2017

Comments Sought on MedSun Reporting Requirements
Federal Register notice: FDA seeks comments on an information collection extension on “Adverse Event Program for Medical Devices.”
05/26/2017

Comments Sought on New Drug Application Requirements
Federal Register notice: FDA seeks comments on an information collection “Application for FDA Approval To Market a New Drug.”
05/26/2017

OMB Approves Several Information Collections
Federal Register notice: FDA publishes a list of information collections that have been approved by the Office of Management and Budget.
05/25/2017

Comments Sought on Advisory Committee Nominations
Federal Register notice: FDA seeks comments on an information collection for “FDA Advisory Committee Membership Nominations — OMB Control Number 0910.
05/24/2017

Comments Sought on Strategic Stockpile Labeling Exceptions
Federal Register notice: FDA seeks comments on an information collection extension on “Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile — OMB Control Number 0910–0614.”
05/24/2017

Comments Sought on User Fee Waiver Guidance
Federal Register notice: FDA seeks comments on an information collection extension for its “Guidance for Industry — User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.”
05/23/2017

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