FDA Stakeholder Update - November 26, 2019

Request for Comment

Dear Health Care Provider Letters: Improving Communication of Important Safety Information by December 23, 2019 This information collection supports recommendations found in the Agency guidance document entitled “Dear Health Care Provider Letters: Improving Communication of Important Safety Information.” The guidance provides instruction to industry and FDA staff on the content and format of Dear Health Care Provider (DHCP) letters. These letters are sent by manufacturers or distributors to health care providers to communicate an important drug warning, a change in prescribing

information, or a correction of misinformation in prescription drug promotional labeling or advertising. CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances by February 18, 2020 This draft guidance is intended for veterinarians, State-licensed pharmacies, and Federal facilities interested in compounding animal drugs from bulk drug substances for use in nonfood-producing animals or for use as antidotes in food-producing animals under limited circumstances when no other medically appropriate treatment options exist. Transdermal and Topical Delivery Systems - Product Development and Quality Considerations by February 20, 2020 This draft guidance provides recommendations to applicants and manufacturers of transdermal and topical delivery systems (TDS) regarding the pharmaceutical development and quality information to include in new drug applications (NDAs) and abbreviated new drug applications (ANDAs). , Specifically, the guidance discusses FDA’s current thinking on product design and pharmaceutical development, manufacturing process and control, and finished product control. It also addresses special considerations for areas where quality is closely tied to product performance and potential safety issues, such as adhesion failure and the impact of applied heat on drug delivery. Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products by February 25, 2020 The purpose of this guidance is to provide recommendations to applicants regarding whether and when comparative clinical immunogenicity studies may be needed to support licensure of proposed biosimilar and interchangeable recombinant human insulins, recombinant human insulin mix products, and recombinant insulin analog products that are intended for the treatment of patients with Type 1 or Type 2 diabetes mellitus (collectively described as “insulin products”). The recommendations in this guidance are applicable only to proposed biosimilar and interchangeable insulin products seeking licensure under section 351(k) of the Public Health Service Act (PHS Act) in biologics license applications (BLAs).