FDA Policy/General

Latest Federal Register Notices

Annual Report on Post Marketing Requirements/Commitments
Federal Register notice: FDA announces the availability of its annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.” 11/16/2018

Consumer Reps Needed for Advisory Committees
Federal Register notice: FDA seeks consumer organizations interested in participating in the selection of voting and nonvoting consumer representatives to serve on its advisory committees or panels. 11/16/2018

FDA Posts PMA, HDE Approval Notices
Federal Register notice: FDA publishes a list of PMAs and humanitarian device exemption applications that have been recently approved. 11/16/2018

FDA Public Meetings on e-Adverse Event Reports
Federal Register notice: FDA announces three public meetings entitled “Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) Using International Council for Harmonization (ICH) E2B(R3) Standards.” 11/15/2018

Proposal to Allow Informed Consent Exceptions
Federal Register proposed rule: FDA proposes to amend its regulations to implement a provision of the 21st Century Cures Act that would allow an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject. 11/15/2018

Workshop on Drug-caused Blood Pressure Effects
Federal Register notice: FDA announces a 2/4 public workshop entitled “Evaluating the Pressor Effects of Drugs.” 11/14/2018

Guide on Nonmetastatic, Castration-Resistant Prostate Cancer
Federal Register notice: FDA makes available a draft guidance entitled “Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials.” 11/14/2018

Info Collection on Device Fees for Small Businesses
Federal Register notice: FDA seeks comments on an information collection extension on a guidance for “Medical Device User Fee Small Business Qualification and Certification.” 11/13/2018

Info Collection on IND Sponsor Surveys
Federal Register notice: FDA submits to OMB a new information collection entitled “Surveys and Interviews With Investigational New Drug (IND) Sponsors To Assess Current Communication Practices With FDA Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act (PDUFA VI).” 11/13/2018

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