FDA Policy/General

Latest Federal Register Notices

FDA Seeks Comments on Reducing Regulation Burden
Federal Register multiple notices: FDA seeks comments to help it identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced to achieve meaningful burden reduction. 09/08/2017

Workshop on Self-collection Devices for Pap Testing
Federal Register notice: FDA announces a 1/11/2018 public workshop entitled “Self-Collection Devices for Pap Test” that will obtain feedback about self-collection devices for cervical samples for Pap testing. 09/08/2017

Guidance on Tissue/Cell Therapy Deviation Reporting
Federal Register notice: FDA makes available a guidance on “Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271.” 09/07/2017

Workshop on CDER Rare Disease Drug Development
Federal Register notice: FDA announces a 10/30 public workshop entitled “CDER Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development.” 09/07/2017

Guidance on Interoperable Medical Devices
Federal Register notice: FDA makes available a guidance on “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” 09/06/2017

Public Meeting on Grandfathered Dietary Supplements
Federal Register notice: FDA announces a 10/3 public meeting entitled “Development of a List of Pre-DSHEA Dietary Ingredients.” 09/06/2017

Ritalin NDA Not Withdrawn Due to Safety/Effectiveness: FDA
Federal Register notice: FDA determines that a Novartis NDA for Ritalin LA (methylphenidate hydrochloride) extended-release capsules, 60 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. 09/06/2017

Gynorest Not Withdrawn Due to Safety/Effectiveness: FDA
Federal Register notice: FDA determines that a Solvay Pharmaceuticals NDA for Gynorest (dydrogesterone) oral tablets, 5 mg and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. 09/06/2017

Draft Guide on REMS eSubmissions
Federal Register notice: FDA makes available a draft guidance on “Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling.” 09/05/2017

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

Read more

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