FDA Policy/General

Latest Federal Register Notices

Panel to Review Ciprofloxacin Dispersion for Inhalation NDA
Federal Register notice: FDA announces a 1/11/2018 Antimicrobial Drugs Advisory Committee meeting. to review an NDA for ciprofloxacin dispersion for inhalation. 12/01/2017

Meticorten Not Withdrawn Due to Safety/Effectiveness: FDA
Federal Register notice: FDA determines that Schering’s Meticorten (prednisone) tablets were not withdrawn from sale for reasons of safety or effectiveness. 12/01/2017

68 ANDA Approvals Withdrawn: FDA
Federal Register notice: FDA announces the withdrawal of 68 ANDAs from multiple applicants. 12/01/2017

FDA Proposes 510(k) Exemption for Surgical Apparel
Federal Register notice: FDA announces its intent to exempt certain subtypes of surgical apparel from premarket notification requirements, subject to conditions and limitations. 11/30/2017

Draft Guide on Dual 510(k) and CLIA Waiver
Federal Register notice: FDA makes available a draft guidance entitled “Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.” 11/30/2017

Public Hearing on Evaluating Nicotine Replacement Products
Federal Register notice: FDA announces a 1/26/2018 public hearing on its approach to evaluating the safety and efficacy of nicotine replacement therapy products, including how they should be used and labeled. 11/30/2017

Regulatory Review Period Determined for Xuriden
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Wellstat Therapeutics’ Xuriden (uridine triacetate), indicated for treating hereditary orotic aciduria. 11/29/2017

Regulatory Review Period Determined for Veltassa
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Relypsa’s Veltassa (patiromer sorbitex calcium), indicated for treating hyperkalemia. 11/29/2017

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