FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Premarket Approval of Medical Devices” (OMB Control Number 0910-0231). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on proposed research on “Health Care Providers’ Understanding of Opioid Analgesic Abuse Deterrent Formulations (ADF).” FDA says its own research and other evidence suggests considerable variability in health care providers’ knowledge of and attitudes toward prescription opioid products and practices. The study is
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV–I/II).” The document provides recommendations about using serological tests to reduce the risk of HTLV–I/II transmission
FDA Policy/General
Ropes & Gray says that FDA and the Justice Department “took significant regulatory and judicial action in 2019 that brought attention to alleged compliance gaps across the medical and health product industries, focusing on entities potentially making higher-risk products and on foreign and domestic facilities that may have received
FDA Policy/General
Federal Register notice: FDA has announced a 3/11 Nonprescription Drugs Advisory Committee meeting. Panel members will review information submitted to the agency in response to an FDA request entitled “Food Handler Antiseptic Drug Products for Over-the-Counter Human Use; Request for Data and Information.” The information reviewed will
FDA Policy/General
Federal Register notice: FDA has announced a 4/22 public meeting on “Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.” The meeting will seek stakeholder input related to data standards and the electronic submission system’s past performance, future targets, emerging industry needs, and technology initiatives.
FDA Policy/General
Federal Register notice: FDA in collaboration with the Federal Trade Commission have announced a 3/9 public workshop: “FDA/FTC Workshop on a Competitive Marketplace for Biosimilars.” The workshop will discuss the agencies’ efforts to support appropriate adoption of biosimilars, discourage false or misleading communications about biosimilars, and deter anticompetitive
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products — Questions and Answers.” The document provides information for sponsors to consider when developing FDA-regulated promotional labeling and advertisements for such products. To view the notice, click
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Evig LLC (dba Balance of Nature), St. George, UT (8/20/2019): FDA inspected the company 2/2019 and cited serious violations of the Federal Food, Drug, and Cosmetic
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products.” The collection supports agency guidance that encourages drug/biologic manufacturers to develop a written emergency plan for maintaining an adequate supply of
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Application for Participation in FDA Fellowship and Traineeship Programs.” The collection involves brief online applications completed by applicants applying to FDA’s fellowship and traineeship programs. The process is intended to reduce the time and cost of
FDA Policy/General
Federal Register notice: FDA has renewed for two years its Vaccines and Related Biological Products Advisory Committee charter. The new charter will be in effect until 12/31/2021. To view the notice, click here.
FDA Policy/General
Guide on Retroviral Vector-Based Gene Therapies Federal Register notice: FDA makes available a final guidance on testing retroviral vector-based human gene therapy products. 01/31/2020 Guide on Gene Therapy Observational Studies Federal Register notice: FDA makes available a final guidance entitled “Long Term Follow-Up After Administration
FDA Policy/General
Federal Register notice: FDA has made available a final guide entitled “Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry.” The document provides recommendations on the identification and amount of material to be tested, and general
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Long Term Follow-Up After Administration of Human Gene Therapy Products.” The document provides recommendations on designing long-term follow-up observational studies for collecting data on delayed adverse events following gene therapy administration. To view the notice, click
FDA Policy/General
FDA 1/31 issued a Warning Letter to Smart Toothpicks (Tempe, AZ) after the agency determined that its dissolvable tobacco products, Peppermint Ice Nicotine, are modified risk tobacco products being marketed without FDA consent. Additionally, the agency determined that its dissolvable tobacco products fail to include required nicotine warning statements.
FDA Policy/General
Federal Register notice: FDA makes available a draft guidance entitled “Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components.’’ The recommendations apply to blood and blood component collection intended for transfusion or for use in further manufacturing.
FDA Policy/General
FDA commissioner Stephen Hahn says “unleashing the power of data” will be a key objective while he is at the helm. In his first all hands address to FDA employees 1/31, Hahn said that attaining more and better data to support the work the agency is doing will be
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Guidance for Industry.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Human Gene Therapy for Hemophilia; Guidance for Industry.” The document provides recommendations on the clinical trial design and related development for coagulation factor VIII (hemophilia A) and IX (hemophilia B) activity assays, including how to address discrepancies in activity
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.” The document provides FDA’s current thinking on the criteria to determine sameness of human gene therapy products. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA makes available a final guidance entitled “Human Gene Therapy for Retinal Disorders; Guidance for Industry.” The document provides recommendations to stakeholders about product development, preclinical testing, and clinical trial design for such products. To view the notice, click here.