FDA Policy/General

Latest Federal Register Notices

Proposal to Withdraw 4 NDAs
Federal Register notice: FDA proposes to withdraw approval of four NDAs from multiple NDA holders because they have repeatedly failed to file required annual reports. 11/15/2019

OTC Drugs Panel Charter Renewal
Federal Register notice: FDA announces the renewal of the Nonprescription Drugs Advisory Committee for an additional two years. 11/15/2019

Info Collection on Device Q-Submission Program
Federal Register notice: FDA sends to OMB an information collection extension for “Q-Submission Program for Medical Devices.” 11/15/2019

Info Collection for Radiation Product Testing
Federal Register notice: FDA seeks comments on an information collection extension for “Testing Communications on Medical Devices and Radiation-Emitting Products.” 11/15/2019

Final Guide on Export Certificate Denials
Federal Register notice: FDA makes available a final guidance entitled “Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices.” 11/14/2019

Info Collection on Cardiovascular Outcome Claims Guide
Federal Register notice: FDA sends to OMB an information collection extension for “Hypertension Indication: Drug Labeling For Cardiovascular Outcome Claims.” 11/14/2019

Info Collection Extension on Device Quality System
Federal Register notice: FDA submits to OMB an information collection extension for “Medical Devices: Current Good Manufacturing Practice Quality System Regulation — 21 CFR Part 820.” 11/14/2019

Workshop on Clinical Outcome Assessments
Federal Register notice: FDA announces a 12/6 public workshop on incorporating clinical outcome assessments into endpoints for regulatory decision making. 11/13/2019

Info Collection on Combo Product Jurisdiction
Federal Register notice: FDA sends to OMB an information collection extension for “Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications — 21 CFR Part 3.” 11/12/2019

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