For regulatory affairs and life sciences professionals, staying on top of evolving FDA guidelines is more than a best practice—it’s a necessity. This past week (with release dates beginning on or after January 7th, 2025) the FDA rolled out several new and updated guidances that span a range of areas, from clinical trial design and obesity treatment to food safety and donor eligibility. Below is a rundown of the most significant releases and what they mean for industry stakeholders in 2025 and beyond.
The FDA issued a draft guidance titled “Developing Drugs for Optical Imaging.” This guidance is aimed at sponsors developing drugs used with imaging devices during surgical procedures to enhance tumor detection or highlight normal anatomical structures. According to the FDA, the goal is to offer clarity on clinical trial design features that support the approval of such drugs. The document underscores and emphasizes the increasing role of intraoperative imaging in improving surgical outcomes and patient safety. It outlines the key considerations for optical imaging clinical trials, including trial populations, trial design, and efficacy considerations.
• For more details, visit the FDA's official page to read the draft guidance in its entirety.
A revised guidance entitled “Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction” was issued by the FDA. This document updates the draft guidance on developing weight management products, originally published in 2007, nearly 20 years ago. The revised guidance provides modernized, updated recommendations on clinical trial designs and endpoints for drugs and biologics intended for long-term weight reduction, reflecting advancements in our understanding of obesity and its treatment. DXA scans were highlighted as a key safety assessment.
• Access the updated draft guidance here.
In support of its Closer to Zero initiative, the FDA has finalized the guidance “Action Levels for Lead in Processed Food Intended for Babies and Young Children.” This document provides the background and rationale behind the FDA’s action levels for lead in processed foods intended for babies and young children. In this scenario, “processed food” refers to packaged products (e.g., jars, pouches, tubs, or boxes) marketed for children under two years old. These may include both ready-to-eat items (e.g., purees) and semi-prepared products (e.g., dry infant cereals).
The document establishes action levels for lead in various categories of these processed foods, aiming to reduce exposure while providing continued access to nutritious products—and ensure continuous, industry-wide reduction over time.
• Read the guidance here.
The draft guidance “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway” was issued to determine clarification. For drugs granted accelerated approval, sponsors are required to complete post-approval confirmatory studies to verify and describe the expected effect on irreversible morbidity, mortality, or other clinical benefits. This draft guidance outlines the FDA's interpretation of the term "underway" and details the policies for meeting this requirement, including the factors the FDA will consider when determining whether a confirmatory trial is underway before granting accelerated approval. granting accelerated approval.
• Read more here.
Physiological differences between females and males can result in variations in disease presentation, pharmacokinetics, pharmacodynamics, and treatment response. Analyzing these sex-related differences in medical product response is essential for evaluating product safety and effectiveness and can guide the content of product labeling. Recognizing the importance of sex-specific data in drug development, the FDA released a draft guidance titled “Study of Sex Differences in the Clinical Evaluation of Medical Products.”
The guidance provides recommendations on:
In collaboration with the Office for Human Research Protections, the FDA issued a draft guidance titled “Considerations for Including Tissue Biopsies in Clinical Trials.” This guidance aims to assist industry, investigators, and IRBs—in equal measure—in understanding ethical and operational considerations when including tissue biopsies in clinical trials involving investigational medical products. investigational medical products.
• Learn more in the full draft guidance.
The FDA issued four draft guidances and two final guidances on human cells, tissues, and cellular and tissue-based products (HCT/Ps) regarding donor eligibility determinations. These documents aim to provide updated recommendations on assessing donor eligibility and maintaining appropriate safeguards.
According to Dr. Peter Marks, Director of CBER, the goal is to expand the pool of eligible donors while ensuring the highest standards of safety for these products.
Lastly, the FDA issued a final guidance titled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act.” This guidance outlines manufacturer obligations to notify the FDA of potential disruptions in supply during public health emergencies. To help stakeholders better understand the guidance, the FDA will host a webinar on March 4, 2025.
• Read the final guidance here.
The breadth of these updates reflects the FDA’s ongoing efforts to enhance regulatory clarity and ensure public health safety across various sectors. As 2025 continues, and regulatory guidelines continue to evolve, understanding these changes is critical for maintaining compliance and advancing product development.
Need assistance with for your FDA communications or regulatory strategy? Bracken’s team of Regulatory Affairs experts is here to help. Contact us today to learn more.
DXA was detailed as the key assessment in the Guidance for weight management due to the ability to distinguish muscle and adipose tissue. Colin Miller, PhD, has built 5 DXA core labs either from the ground up or supporting clients, so we understand the assessment and the challenges. Contact us today to learn more.