FDA’s CDER announces updated guidance agenda for 2025

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has released a new guidance agenda outlining the new and revised guidance documents scheduled for release this year.

This year, a revised draft of the question-and-answer guidance on biosimilar development under the Biologics Price Competition and Innovation (BPCI) Act of 2010 has been added to the list.

This guidance aims to facilitate the development of biosimilar and interchangeable biosimilar products. It was not included in the earlier list issued this year, and this marks the fourth revision of the guidance. The third version of the Q&A guidance was issued in September 2021 (RELATED: FDA finalizes more Q&As on biosimilar development, Regulatory Focus, 20 September 2021)

The new list includes 87 guidelines scheduled for release, many of which are carried over from the January 2025 agenda.

Other changes include the removal of the draft guidance on the REMS logic model, which is a framework that connects program design with assessment. The FDA released guidance on this topic in May 2024. (RELATED: FDA unveils draft guidance on REMS logic models, Regulatory Focus 6 May 2024).

FDA has also removed its draft enforcement policy regarding animal-derived thyroid products that lack an approved biologics license application.

Most of the upcoming new and revised guidelines focus on generic drugs. Some of the planned documents include a draft guidance on the 30-month stay of approval for an Abbreviated New Drug Application (ANDA) or a 505(b)(2) application. Additionally, guidelines will cover ANDAs for certain highly purified synthetic peptide drug products that reference listed drugs of recombinant DNA origin, as well as the content and format required for ANDA submissions. There will also be guidance on the refusal to accept ANDA submissions due to deficiencies in Drug Master Files (DMFs).
 

In the pharmaceutical quality/chemistry, manufacturing, and controls (CMC) area, FDA plans to issue new guidance on stability testing for ANDAs in a question-and-answer format and guidance on container closure systems for drugs, including biological products. The agency also plans to issue a revised draft for current GMPs for medical gases and a revised draft on the certification process for designated medical gases.

In the pharmaceutical quality cGMP areas, FDA plans to issue new guidance on approaches to meeting CGMP requirements for distributed manufacturing, laboratory testing drugs held in interstate commerce, and responding to Form 483 observations at the conclusion of a drug cGMP inspection. The agency also plans to issue revised draft guidance on current good manufacturing practices (GMPs) for PET drugs.
CDER states that it is not required to adhere to this list and may issue guidance documents that are not included.
 
Agenda