FDA Policy/General

Latest Federal Register Notices

Guide on Submitting ANDA or 505(b)(2) NDA
Federal Register notice: FDA makes available a guidance entitled “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” 05/10/2019

Topical Active Ingredients for OTC Monograph Guide
Federal Register notice: FDA makes available a final guidance entitled “Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.” 05/10/2019

Guide on Oncology Drug Reproductive Toxicity Testing
Federal Register notice: FDA makes available a final guidance entitled “Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations.” 05/10/2019

Draft Guide on Real World Data Submissions
Federal Register notice: FDA makes available a draft guidance entitled “Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics.” 05/09/2019

Pregnancy Safety Studies Draft Guide
Federal Register notice: FDA makes available a draft guidance entitled “Postapproval Pregnancy Safety Studies” that provides recommendations on how to design investigations to assess the outcomes of pregnancies in women exposed to drugs/biologics. 05/09/2019

Draft Guide on Lactation Study Designs
Federal Register notice: FDA makes available a draft guidance entitled “Clinical Lactation Studies: Considerations for Study Design.” 05/09/2019

New DTC Study on Accelerated Approval Disclosures
Federal Register notice: FDA submits to OMB a new information collection entitled “Experimental Study of an Accelerated Approval Disclosure.” 05/08/2019

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