FDA Policy/General

Latest Federal Register Notices

Draft Guide on Drug Indications Labeling
Federal Register notice: FDA makes available a draft guidance entitled “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.” 07/09/2018

Comments Sought on Biosimilar Info Collection
Federal Register notice: FDA seeks comments on a information collection extension for “General Licensing Provisions; Section 351(k) Biosimilar Applications.” 07/09/2018

Panel to Review Insmed Lung Disease Drug
Federal Register notice: FDA announces an 8/7 Antimicrobial Drugs Advisory Committee meeting. 07/09/2018

Guide on Biosimilar User Fee Program
Federal Register notice: FDA makes available a final guidance entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” 06/29/2018

Draft Guide on Oncology Therapeutic Radiopharmaceuticals
Federal Register notice: FDA makes available a draft guidance entitled “Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations.” 06/29/2018

Workshop on Non-traditional Therapies for Bacterial Infections
Federal Register notice: FDA announces an 8/22 public workshop entitled “Development of Non-Traditional Therapies for Bacterial Infections.” 06/28/2018

Comments Sought on Biosimilar Fee Program Info Collection
Federal Register notice: FDA seeks comments on an information collection extension for “Biosimilars User Fee Program.” 06/28/2018

Hearing on FDA’s Predictive Toxicology Roadmap
Federal Register notice: FDA announces a 9/12 public hearing to solicit comments on its Predictive Toxicology Roadmap. 06/28/2018

Info Collection Extension on State Enforcement Notifications
Federal Register notice: FDA files for OMB approval a proposed information extension for “State Enforcement Notifications.” 06/27/2018

Panel to Review Malaria Drug NDA
Federal Register notice: FDA announces a 7/26 Antimicrobial Drugs Advisory Committee meeting that will review a 60 Degrees Pharmaceuticals NDA for a malaria drug. 06/26/2018

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