FDA Policy/General

Latest Federal Register Notices

CDRH Listing on Upcoming Guidance Documents
Federal Register notice: FDA announces its Web site address where CDRH will post two lists of guidance documents that the Center intends to publish in fiscal year 2020. 10/11/2019

Info Collection on 510(k) 3rd-party Reviews
Federal Register notice: FDA submits to OMB an information collection extension for “510(k) Third-Party Review Program.” 10/11/2019

Info Collection Extension for CVM eSubmissions
Federal Register notice: FDA sends to OMB an information collection extension for a guidance on cvm’s electronic submission system. 10/11/2019

Info Collection Extension for Outsourcing Facilities
Federal Register notice: FDA submits to OMB an information collection extension for electronic drug product reporting for drug compounding outsourcing facilities. 10/10/2019

Final Guide on Intravascular Catheter Labeling
Federal Register notice: FDA makes available a final guidance entitled “Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings-Labeling Considerations.” 10/10/2019

Guide on Guidewire Testing and Labeling
Federal Register notice: FDA makes available a final guidance on coronary, peripheral, and neurovascular guidewire testing and labeling. 10/10/2019

Final Guide on IVDs in Oncology Trials
Federal Register notice: FDA makes available a final guidance entitled “Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.” 10/10/2019

Workshop on Pediatric Clinical Trial Endpoints
Federal Register notice: FDA announces an 11/12 public workshop on patient perspectives in pediatric clinical trial endpoints for rare diseases. 10/09/2019

Priority Voucher Awarded to Bavarian Nordic
Federal Register notice: FDA announces that it has issued a material threat medical countermeasure priority review voucher to Bavarian Nordic for recently approved Jynneos (smallpox and monkeypox vaccine). 10/09/2019

New Info Collection on FDA Fellowship Programs
Federal Register notice: FDA submits to OMB a new information collection conflict of interest information for non-employee fellowship programs participants. 10/08/2019

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