FDA Policy/General

Latest Federal Register Notices

Orthopedic Surgical Instruments Put Into Class 2
Federal Register notice: FDA classifies orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into Class 2 (special controls). 10/25/2019

Draft Guide on Homeopathic Drug Products
Federal Register notice: FDA makes available a revised draft guidance entitled “Drug Products Labeled as Homeopathic.” 10/25/2019

Allergan NDA Lo Minastrin FE Withdrawn
Federal Register notice: FDA withdraws the NDA approval of Allergan Pharmaceuticals’ Lo Minastrin FE because it is no longer marketed. 10/25/2019

Internal Therapeutic Massagers Put Into Class 2
Federal Register notice: FDA classifies internal therapeutic massagers into Class 2 (special controls). 10/25/2019

Five Class 2 Devices Exempt from 510(k)
Federal Register notice: FDA announces its decision to exempt a list of Class 2 devices from premarket notification requirements. 10/25/2019

Draft Guide on Postmarketing Studies/Trials
Federal Register notice: FDA makes available a draft guidance entitled “Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.” 10/24/2019

Device Recognized Standards List Modified
Federal Register notice: FDA makes available its listing of “Modifications to the List of Recognized Standards, Recognition List Number: 052.” 10/24/2019

Draft Guide on Breast Implant Labeling
Federal Register notice: FDA makes available a draft guidance entitled “Breast Implants — Certain Labeling Recommendations to Improve Patient Communication.” 10/24/2019

Info Collection Extension for Social and Behavioral Research
Federal Register notice: FDA sends to OMB an information collection extension for “Data to Support Social and Behavioral Research as Used by the Food and Drug Administration.” 10/24/2019

Proamatine Not Withdrawn Due to Safety/Efficacy
Federal Register notice: FDA determines that Shire’s Proamatine (midodrine hydrochloride) tablets, 2.5milligrams (mg), 5mg, and 10 mg, were not withdrawn from sale for safety or effectiveness reasons. 10/21/2019

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