FDA Roundup: September 22, 2023

FDA News Release

• For Immediate Release: September 22, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• On Thursday, the FDA issued the revised, draft guidance Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products. This draft guidance outlines the recommendations to industry on formal meetings between the FDA and sponsors or applicants relating to the development and review of drug or biological drug products.  This draft guidance replaces the draft guidance Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products issued on December 29, 2017.
• On Wednesday, the FDA  provided an update on its work to advance its strategy to help prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula. The update noted significant actions that have been taken to advance the goals of the strategy which can be found on the prevention strategy webpage.
• On Tuesday, the FDA announced that the Accreditation Scheme for Conformity Assessment (ASCA) program is converting from a pilot to a permanent program. This transition is authorized by the Medical Device User Fee Amendments of 2022 (MDUFA V). ASCA is a voluntary accreditation program that capitalizes on the increasingly prominent role of consensus standards in regulatory science. The ASCA program’s goals are to streamline conformity assessment in medical device submissions, enhance the FDA’s confidence in test methods and results, decrease the need for additional information related to conformance with a standard, and promote consistency, predictability and efficiency in medical device review.
• On Tuesday, the FDA issued the draft Center for Devices and Radiological Health International Harmonization Strategic Plan. This plan includes specific strategies to directly encourage harmonization, convergence, and reliance among medical device regulatory authorities, as applicable, and builds on the work CDRH is currently doing with international stakeholders. As the design, manufacture, distribution and use of medical devices have become increasingly complex and global, the need for harmonized approaches and reliance among regulatory authorities has become more vital. You can read the CDRH Statement here.
• The FDA Office of Women’s Health (OWH) works to protect, promote, and advance the health of women through research, education, and outreach. In collaboration with the Center for Drug Evaluation and Research (CDER) Office of Clinical Pharmacology (OCP), OWH will host a free public workshop on October 11, 2023, Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research. The workshop will include presentations and session discussions by experts in the fields of clinical pharmacology, obstetrics and gynecology, endocrinology, and clinical care. Speakers will discuss the current understanding of the impact of menopause on the pharmacokinetics and pharmacodynamics (the movement of drugs through the body, and the body’s biological response to drugs, respectively), and exposure-response relationships of FDA-regulated drugs and biological products used by menopausal women for non-menopause-related indications. Researchers, educators, clinicians, and patients may benefit from attending this scientific workshop, which will be held virtually. To receive a link to attend, please register in advance.