FDA Regulatory News and Trends - June 17, 2024

Welcome to FDA Regulatory News and Trends, designed to help you identify significant legal developments and navigate the evolving business, legal, and regulatory world.

Two draft guidance documents on bioresearch monitoring.

• On June 4, 2024, FDA's Center for Biologics Evaluation and Research (CBER) issued two draft guidance documents on bioresearch monitoring (BIMO), “Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center for Biologics Evaluation and Research Submissions” and “Processes and Practices Applicable to Bioresearch Monitoring Inspections.”  
  
  
• The first draft guidance, when finalized, will provide additional information regarding the format to be used for electronic submission of biologics license applications (BLA), new drug applications (NDA), and certain supplemental application content for planning and conducting CBER BIMO inspections, using the Electronic Common Technical Document.
  
  
• The second draft guidance covers the types of records and information required to be provided, best practices for communication between FDA and industry in advance of or during an inspection or request for records or other information, and other inspection-related conduct.
  
  
• Interested parties should submit comments on or before August 5, 2024.

FDA releases draft guidance encouraging the use of platform technologies for drug development.

• On May 29, 2024, FDA released a draft guidance document entitled, "Platform Technology Designation Program for Drug Development: Guidance for Industry." This long-awaited draft guidance supports an expedited review pathway for products that receive a platform technology designation from the Agency.
  
  
• A platform technology is defined as a well-understood and reproducible technology, such as a nucleic acid sequence, molecular structure, mechanism of action, delivery method, vector, or any combination thereof. A platform technology:
  
  
  • Can be incorporated in or used by a drug or biological product and is essential to the structure or function of the drug or biological product
    
    
  • Can be adapted for, incorporated into, or used by one or more drug or biological products sharing common structural elements, or
    
    
  • Facilitate the manufacture or development of drug or biological products through a standardized manufacturing production or manufacturing process or processes. 
    
    
• Platform technologies offer the potential to revolutionize drug development by creating greater efficiencies in manufacturing and regulatory review. Drug and biologic companies are encouraged to review this guidance and consider whether they may be able to leverage platform technologies and the associated expedited review pathway. Comments on the draft guidance can be submitted to docket number: FDA-2024-D-1829.
  
  
• For a deeper dive into this topic, please see our recent client alert.
   

Final rule allowing FDA to destroy certain devices refused admission into the US.

• On May 31, 2024, FDA issued a final rule as part of the Safeguarding Therapeutics Act (Pub. L. 116-304) that was signed into law on January 5, 2021.
  
  
• This rule implements FDA's authority to administratively destroy human or animal devices valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that have been refused admission into the US. The final rule also establishes a hearing process in which the device owners will receive notice of the intended destruction and will be offered an opportunity to contest the refusal and destruction.
  
  
• Medical device manufacturers importing their devices to the US, and importers involved in medical device importation, are encouraged to review the final rule for awareness and ensure that thorough importation documentation is maintained in case of the need to contest refusal of admission.
  
  

CVM draft guidance on reproduction toxicity testing.

• On May 23, 2024, FDA issued draft guidance, entitled, “CVM GFI #115 (VICH GL22) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Toxicity Testing (Revision 1).”
  
  
• The guidance is part of a series of documents, including, for example, “CVM CFI #159 (VICH GL36(R)) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI,” intended to ensure international harmonization of testing done to evaluate the residues of veterinary drugs in human foods. They were developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) Expert Working Groups, in which the appliable regulatory bodies of the US, European Union, and Japan participate.  
  
  
• Interested parties can submit comments to the draft guidance by July 22, 2024.

FDA joins three new medical device collaborative communities.

• FDA recently began participating in three new collaborative communities: the i) Implantable Brain-Computer Interface Collaborative Community (iBCI-CC); ii) OpenOximetry Collaborative Community; and iii) Smart and Autonomous Medical Systems (SaAMS) Collaborative Community. 
  
  
• All of these communities aim to address challenges and opportunities in the development and use of AI-enabled medical devices, such as brain implants, pulse oximeters, and autonomous surgical robots.
  
  
• FDA currently participates as a member of 17 collaborative communities and is open to participating in others.  

START Pilot Program participants selected.

• On May 31, 2024, FDA notified selected participants of their acceptance into the Support for Clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program, which the Agency initially introduced in October 2023. 
  
  
• FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) initiated the START Pilot Program to help further accelerate the development of novel drug and biological products for rare diseases. Selected participants will be able to obtain frequent advice and enhanced communication from FDA staff to address program-specific development issues such as clinical study design, choice of control group, finetuning the choice of patient population, leveraging nonclinical information, and product characterization. 
  
  
• While FDA has not disclosed how many participants it has selected, several of the selected sponsors have individually announced their acceptance into the program.

New OCE Equity Program announced.

• On May 20, 2024, FDA’s Oncology Center of Excellence (OCE) announced the formation of the OCE Equity Program, which continues the OCE’s work to improve access to clinical trials of oncology medical products for populations that have been historically underrepresented in clinical research. 
  
  
• The Program is a public health initiative intended to improve access for populations such as racial and ethnic minorities; individuals who live in rural areas; sexual and gender minorities; and individuals with economic, linguistic, or cultural barriers to healthcare services. 
  
  
• The OCE Equity Program seeks to advance equitable access to clinical trials for all patients with cancer through policy, research, and education by engaging with stakeholders and conducting analyses of data generated through clinical trials and other data sources to evaluate outcomes across subgroups.