Earlier this month, FDA’s Center for Biologics Evaluation and Research (CBER) published its annual guidance agenda. CBER’s list is published in addition to the FDA’s agency-wide Annual Guidance Agenda (in which CBER’s list is included), which outlines the guidance documents the Agency plans to publish during the 2016 calendar year.
The Center’s list “includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CBER has already issued Level 1 drafts that may be finalized following review of public comments.” Broken down by category, CBER’s 2016 guidance agenda includes the following topics:
In its announcement, CBER states that, although it intends to develop the guidance documents on the topics listed above, “the Center is neither bound by this list of topics, nor required to issue every guidance document on this list.” In addition, the Center also states that it is not precluded from developing guidance documents on topics which are not included within the list.
July 20, 2022
FDA Draft Guidance July, 2022 As part of the FDA’s continued efforts to provide helpful information to regulated industry and the public, the agency has published a draft guidance for industry,...
February 3, 2017
Last month, FDA’s Center for Drug Evaluation and Research (CDER) released its annual guidance agenda, announcing the new and revised draft guidances that the Center plans to publish during the 2017...
August 2, 2022
Today, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug...