Pharmaceutical Quality Documents
FDA launched a new search function relating to the Pharmaceutical Quality Resources. The new search webpage scans existing FDA guidance documents, manuals of policies and procedures (MAPPs), and compliance programs to provide users with relevant and up-to-date resources and information.
ClinicalTrials.gov Reporting
FDA announced a newly published report on the findings to understand the barriers to timely, accurate, and complete registration and reporting of clinical trial summary results information on ClinicalTrials.gov. The report provides strategies and recommendations for improving registration and results information reporting for applicable clinical trials.
Chimeric Antigen Receptor (CAR) T Cell Products
In November 2023, the FDA posted a safety communication with information related to findings of T cell malignancies reported in patients who received treatment with CAR T cell immunotherapies. In January 2024 this lead to a class wide change of safety labelling and black box warning for all six commercial CAR T therapies, and now the release of the final guidance on Considerations for the Development of CAR T Cell Products, providing recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, and clinical study design.
Final Guidance Issued
Human Gene Therapy Products Incorporating Human Genome Editing (GE) This guidance provides recommendations on what should be provided in an Investigational New Drug (IND) application in order to assess the safety and quality of investigational GE products, and includes information on product design, manufacturing and testing, nonclinical safety assessment, and clinical trial design.
Final Guidance Issued
Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, which describes risk-based principles and mitigation strategies to assure the viral safety of biotechnology products, including the data necessary to submit in a marketing application.
Draft guidance out for comment
The following draft guidance is available for comment: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products. Providing FDA’s expectations for, and recommendations on, use of a standardized approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical trials and clinical studies for FDA-regulated medical products. Submit comments by 29 April 2024.
Revised Draft Guidance
FDA revised the draft guidance, Requests for Reconsideration at the Division Level Under GDUFA, provides recommendations on the procedures for applicants of abbreviated new drug applications (ANDAs) who wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority.
This revision reflects the most recent reauthorization of the Generic Drug User Fee Amendments (GDUFA) and clarifies what matters are appropriate for requests for reconsideration.
Draft Guidance Issued
The draft guidance Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act is intended to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of finished products that are life supporting, life sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition. This applies to applicants with approved new drug applications (NDAs), approved abbreviated new drug applications (ANDAs), or approved biologics license applications (BLAs), plus manufacturers of finished drug products marketed without approved NDAs or ANDAs.
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