FDA Policy/General

Latest Federal Register Notices

Guide on Child-Resistant Packaging Statements
Federal Register notice: FDA announces the availability of a draft guidance on “Child-Resistant Packaging Statements in Drug Product Labeling.” 08/03/2017

FDA Withdraws Approval for 4 B. Braun Medical Drugs
Federal Register notice: FDA announces that it is withdrawing approval of three NDAs and one ANDA held by B. Braun Medical. 08/03/2017

FDA Webinar on OTC Monograph User Fees
Federal Register notice: FDA announces an 8/23 Webinar to provide stakeholders with a status update on the process of FDA and industry discussions on an Over-the- Counter Monograph user fee program that began 7/2016. 08/02/2017

Animal Drug User Fee Rates for 2018
Federal Register notice: FDA announces the fee rates and payment procedures for fiscal year 2018 generic new animal drug user fees. 08/02/2017

2018 User Fee Rates for Drug Compounders
Federal Register notice: FDA announces the fiscal year 2018 rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities. 08/02/2017

User Fee Rates for Animal Drugs
Federal Register notice: FDA announces the rates and payment procedures for fiscal year 2018 animal drug user fees. 08/02/2017

Comments Sought on De Novo Device Submissions
Federal Register notice: FDA seeks comments on a new information collection for “De Novo Classification Process (Evaluation of Automatic Class 3 Designation).” 08/02/2017

FDA Puts Oral Palatal Space Occupying Device Into Class 2
Federal Register notice: FDA classifies as a Class 2 (special controls) medical device the oral removable palatal space occupying device for weight management or weight loss. 07/31/2017

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

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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