FDA Policy/General

Latest Federal Register Notices

Guide on GMPs for Active Pharmaceutical Ingredients
Federal Register notice: FDA makes available a final guidance entitled “Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions and Answers.” 04/20/2018

Draft Guide on Inhalation Drug Products
Federal Register notice: FDA makes available a draft guidance entitled “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products — Quality Considerations.” 04/19/2018

Ultrasonic Diathermy Devices Policy Clarification
Federal Register notice: FDA makes available a guidance entitled “Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices; Guidance for Industry and Food and Drug Administration Staff.” 04/17/2018

Draft Guide on Streamlined Approach for Oncology IVDs
Federal Register notice: FDA makes available a draft guidance entitled “Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.” 04/17/2018

Guide on Special Protocol Assessments
Federal Register notice: FDA makes available a guidance entitled “Special Protocol Assessment (SPA)” that provides information about the procedures and general policies adopted by CDER/CBER for such assessments. 04/17/2018

Guide on Caffeine in Dietary Supplements
Federal Register notice: FDA makes available a guidance on “Highly Concentrated Caffeine in Dietary Supplements.” 04/17/2018

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