FDA Policy/General

Latest Federal Register Notices

Advisory Panel to Review Bayer Drug
Federal Register notice: FDA announces an 11/16 Antimicrobial Drugs Advisory Committee meeting that will review a Bayer NDA for ciprofloxacin inhalation powder, indicated for reducing exacerbations in non-cystic fibrosis bronchiectasis adult patients. 09/29/2017

Guide on Advancing Emerging Technology In Drug Manufacturing
Federal Register notice: FDA makes available a guidance entitled “Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization.” 09/29/2017

Guide on Oncology Reproductive Toxicity Testing
Federal Register notice: FDA makes available a draft guidance entitled “Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations.” 09/29/2017

Comments Sought on Opioid Policy Committee
Federal Register notice: FDA seeks comments or suggestions on issues relevant to the agency’s newly established Opioid Policy Steering Committee. 09/29/2017

FDA Seeks Non-voting Members for Device Advisory Panels
Federal Register notice: FDA requests that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee notify the agency in writing. 09/28/2017

Mammography Quality Advisory Committee Renewed for 2 Years
Federal Register notice: FDA announces the renewal of the National Mammography Quality Assurance Advisory Committee. 09/27/2017

Public Hearing on New Device Use with Approved Drugs
Federal Register notice: FDA announces an 11/16 public hearing on a potential approach for device sponsors who seek to obtain marketing authorization for their products that are labeled for a new use with an approved, marketed drug when the drug sponsor does not wish to collaborate on the new use. 09/26/2017

Guidance on Product Classifications
Federal Register notice: FDA makes available a final guidance entitled “Classification of Products as Drugs and Devices & Additional Product Classification Issues.” 09/26/2017

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