The ball has dropped on the healthcare and life sciences industry’s unique New Year tradition, the J.P. Morgan Healthcare Conference, so all eyes turn to 2024. To help define a path forward, Morgan Lewis FDA and healthcare partners Jacqueline Berman, Rebecca Dandeker, Maarika Kimbrell, and Kathleen Sanzo have assembled an in-depth report on drug and biologic developments at the FDA.
From clinical trial developments and manufacturing to advertising and compliance, the report can provide companies with useful information on any stage of product development and marketing. Read the full report and find our selection of notable takeaways below.
Premarket Considerations
- By implementing the International Council for Harmonisation’s (ICH’s) third revision guidelines on good clinical practice and creating a variety of clinical trial–related guidances, the FDA aims to allow clinical trials to be more agile without sacrificing data integrity and participant protections. The agency’s updates cover a wide variety of trials—including innovative trials like decentralized clinical trials—and incorporate the use of new digital health technologies.
- New guidances specific to combination products and oncology-focused products were also released over the course of the last year, including draft guidance for the oncology accelerated approval process, final guidance for the real-time oncology review program, and final guidance for the agency’s pilot program on the use of oncology drug products with in vitro diagnostic tests.
- In September, the FDA added a new category of meetings, Type D, intended to discuss a narrow set of issues at key development program decision points. Typically, these meetings should address no more than two issues and associated questions.
Drug Manufacturing
- In another alignment with the ICH, the FDA updated its guidance on implementing continuous manufacturing. The guidance addresses considerations that impact the entire development cycle, including quality evaluations, process monitoring and control, and tracking for traceability and diversion of nonconforming products.
- The Center for Drug Evaluation and Research’s Office of Pharmaceutical Quality announced a planned reorganization, with the goal of developing its lifecycle approach to product regulation, centralizing research functions, and reinforcing “stronger connections between assessment, inspection, surveillance, research, policy, and administrative operations.”
- After adopting alternative tools such as remote regulatory assessments and remote interactive evaluations during the COVID-19 pandemic, the FDA took steps this year to formalize the rules around these processes. This continued through December 2023, when the agency issued draft guidance on its new Advanced Manufacturing Technologies Designation Program, which relates to novel manufacturing technologies or established technologies used in a novel way in the drug and biological production process.
Postmarket Considerations
- In a heavily anticipated draft guidance, the agency revised its approach to the dissemination of scientific information on unapproved uses (SIUU) of approved or cleared medical products. Notably, the draft guidance would expressly permit firm-generated material, provided that it meets the criteria laid out in the draft guidance, which, among other things, requires that any communications regarding SIUU be truthful, non-misleading, factual, and unbiased, and provide healthcare providers with all information that may be necessary to understand the “strengths and weaknesses and validity and utility” of the information being conveyed.
- A new element may be added to the FDA’s human prescription drug labeling regulations for prescription drug products used on an outpatient basis. This “Patient Medication Information” would be a one-page document highlighting essential information. If finalized, the rule would require this information to be included on all new drug applications, biologics license applications, and abbreviated new drug applications on a proposed five-year phased-implementation schedule.
- Implementation of the Drug Supply Chain Security Act (DSCSA) has been a long-term project for the agency, evolving over the last 10 years since the bill passed. Last year alone, the FDA issued seven guidances regarding the bill, clarifying its thinking on suspect and illegitimate product identification; waivers, exceptions, and exemptions; compliance policies; enhanced security requirements at the package level; wholesale distributor and dispenser verification requirements; adoption of DSCSA standards; and verification systems.
If you have any questions about any of these developments or would like assistance on implementing any FDA guidance for your organization, please contact the authors of the report or any member of our FDA and healthcare team.