FDA Policy/General
Federal Register Notice: FDA is making available the summary report of public comments received during the open period from 11/4-12/4/14, on FDA activities under the Food and Drug Administration Safety and Innovation Act, Patient Participation in Medical Product Discussions. An electronic copy of the summary report
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on submission of rotational plans for health warning label statements for smokeless tobacco products. Comments should be submitted by 4/19. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA seeks comments on (1) an extension of the study conducted with the original longitudinal youth cohort developed and surveyed for the outcome evaluation of FDA’s General Market Youth Tobacco Prevention Campaign, (2) the development of a second longitudinal cohort for the purpose of continuing the
FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled Immunogenicity-Related Considerations for Low Molecular Weight Heparin. It discusses how applicants for low molecular weight heparin products should provide information on impurities and their potential impact on immunogenicity. To download this guidance, click here. To view this
FDA Policy/General
Federal Register Notice: FDA is making available a guidance: Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus. The document provides blood establishments that collect blood and blood components with recommendations for donor screening, donor deferral, and product management to reduce
FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations. It is intended to help sponsors determine the amounts and types of safety data to collect based on what is already known
FDA Policy/General
Federal Register Notice: FDA’s Pediatric Advisory Committee will meet 4/12 to discuss pediatric-focused safety reviews of 17 products, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. The meeting will be held from 8 a.m. to 5:30 p.m.
FDA Policy/General
Alliance for a Stronger FDA has urged Congressional appropriators to bump up FDA’s proposed FY 2017 budget request by $120 million (4%) in order for the agency to carry out its responsibilities. The request would increase FDA’s budget, not including user fees, to $2.85 billion. The Alliance
FDA Policy/General
Reforms to FDA are part of six steps to transform healthcare now identified by the National Opinion Research Center (NORC) at the University of Chicago for the Healthcare Leadership Council. The group’s 2/17 report says there is a broad consensus in the U.S. among healthcare providers, payers,
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Substances Generally Recognized as Safe: Notification Procedure — 21 CFR 170.36 and 570.36,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is requesting that any industry organizations interested in participating in the selecting nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee in CDRH notify FDA in writing. The agency is also requesting nominations for nonvoting industry representatives to serve on certain
FDA Policy/General
Federal Register Final order: FDA is issuing a final order to require the filing of a PMA or a notice of completion of a product development protocol for the hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an
FDA Policy/General
Federal Register Notice: FDA’s Center for Tobacco Products (CTP) is soliciting applications from regulated tobacco product manufacturers to participate in a voluntary pilot program to help CTP evaluate a potential new portal, the CTP eSubmissions Portal (CTP Portal), that is being designed to improve the process in connection with
FDA Policy/General
Federal Register Notice: The Science Board to the FDA will meet 3/1, from 8:30 a.m. until 5 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503, Section A), Silver Spring, MD. For those unable to
FDA Policy/General
Federal Register Notice: FDA will hold a public workshop 3/18 entitled “Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy.” Its purpose is to discuss approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR) in
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance: Allergic Rhinitis: Developing Drug Products for Treatment. Its purpose is to assist sponsors in the development of drug products for treating seasonal allergic rhinitis and perennial allergic rhinitis. It revises the draft guidance for industry entitled Allergic Rhinitis: Clinical Development
FDA Policy/General
Federal Register Notice: FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation will hold a public workshop 3/24 entitled “Building the National Evaluation System for Medical Devices: Using Real-World Evidence to Improve Device Safety and Effectiveness.” Its objective is to discuss the scientific
FDA Policy/General
Federal Register Notice: FDA will hold a public workshop 4/5 entitled “Proposed Pilot Project(s) under the Drug Supply Chain Security Act (DSCSA).” It will provide a forum for discussing proposed design objectives of pilot projects that will explore and evaluate methods to enhance the safety and security of
FDA Policy/General
Federal Register Notice: FDA’s Oncologic Drugs Advisory Committee will meet 4/12 from 8:30 a.m. to 1 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss a Clovis
FDA Policy/General
Federal Register Notice: FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify the agency in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry on cyclosporine ophthalmic emulsion entitled Draft Guidance on Cyclosporine. The recommendations provide specific guidance on the design of bioequivalence studies to support ANDAs for cyclosporine ophthalmic emulsion. To download this guidance, click here. To view this notice, click
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Nonallergic Rhinitis: Developing Drug Products for Treatment. The purpose of this draft guidance is to assist applicants in the development of drug and biological products for treating nonallergic rhinitis. To download this guidance, click here. To view