Information for industry

Information for industry RFI (reminder): Development of New Antibacterial Drugs Active Against Multi-Drug Resistant Bacteria - The FDA Center for Drug Evaluation and Research (CDER) Office of Antimicrobial Productsissued a Request for Information (RFI) on September 11, 2018, to solicit informal input from the public and private sectors to obtain external input into developing an annual list of regulatory science initiatives specific for antimicrobial products. Respond by October 31, 2018. Draft guidance - Adaptive Design for Clinical Trials of Drugs and Biologics (PDF, 623 KB) - To help sponsors of investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications develop appropriate adaptive clinical trial designs to support the effectiveness and safety of a drug or biologic. Comment by November 30, 2018. (September 28, 2018) FDA launched the Special 510(k) Program Pilot, which aims to simplify how manufacturers submit certain 510(k)s. The program pilot allows the FDA and industry to test an expansion to the Special 510(k) Program. The goal of the pilot is to determine whether updated factors for eligibility in the Special 510(k) Program will improve the FDA staff’s efficiency in reviewing 510(k) submissions. The FDA would like to increase the number of 510(k) submissions that are appropriate for the Special 510(k) Program. All Special 510(k)s received on or after October 1, 2018 will be included in the program pilot. Comment on the draft guidance The Special 510(k) Program (PDF,  697 KB) by November 27, 2018. On November 8, 2018, FDA will host a webinar about this pilot. (October 1, 2018) Guidance for Sponsors, Investigators, and Institutional Review Boards: Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations (PDF, 95 KB) - Revisions to HHS’ Federal Policy for Protection of Human Research Subjects (45 CFR 46, Subpart A) have created certain differences between FDA’s human subject regulations and HHS’ human subject regulations. While FDA intends to undertake rulemaking to harmonize, to the extent practicable and consistent with other statutory provisions, its regulations with the 2018 Requirements consistent with Section 3023 of the 21st Century Cures Act, we recognize the potential for confusion in the interim for sponsors, investigators, and IRBs who are involved in both HHS-regulated research and FDA-regulated clinical investigations. This guidance is intended to clarify the impact of certain provisions of the 2018 Requirements on FDA-regulated clinical investigations. (October 12, 2018) Draft guidance - Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings (PDF, 132 KB), to assist sponsors of drug and biological products for the treatment of rare diseases in planning and conducting more efficient and productive pre-investigational new drug application (pre-IND) meetings. Comment by December 17, 2018. (October 16, 2018) More: MCM-Related Guidance by Date