Dec 21 -- FDA extends the comment period to February 4, 2022 https://www.federalregister.gov/documents/2021/12/21/2021-27521/data-standards-for-drug-and-biological-product-submissions-containing-real-world-data-draft-guidance
Oct 22 -- The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.” Under section 745A(a) of the FD&C Act (21 U.S.C. 379k-1(a)) and the guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Standardized Study Data” (Study Data Guidance), clinical or nonclinical study data contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) must be in an electronic format that the Agency can process, review, and archive, unless such submission is exempt from the electronic submission requirements or if FDA has granted a waiver.
This guidance clarifies that RWD submitted as study data in NDAs, ANDAs, certain BLAs, and certain INDs are subject to the requirements in section 745A(a) of the FD&C Act (21 U.S.C. 379k-1(a)) and the Study Data Guidance. Currently, as stated in the Study Data Guidance, the Agency can process, review, and archive electronic submissions of clinical and nonclinical study data (including data derived from RWD sources) that use the standards specified in the Catalog posted to FDA's Study Data Standards Resources web page (https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources
). Therefore, submissions subject to section 745A(a) of the FD&C Act that contain study data derived from RWD sources must be in electronic format using the study data standards currently supported by FDA as specified in the Catalog. This guidance provides recommendations to sponsors for complying with section 745A(a) of the FD&C Act when submitting study data derived from RWD sources in an applicable regulatory submission using standards specified in the Catalog.
Section 3022 of the 21st Century Cures Act (Cures Act) amended the FD&C Act to add section 505F, Utilizing Real World Evidence (21 U.S.C. 355g). This section requires the establishment of a program to evaluate the potential use of RWE to help support the approval of a new indication for a drug approved under section 505(c) of the FD&C Act (21 U.S.C. 355(c)) and to help support or satisfy postapproval study requirements. This section also requires that FDA use the program to inform guidance for industry on the circumstances under which sponsors of drugs may rely on RWE and the appropriate standards and methodologies for collection and analysis of RWE submitted to evaluate the potential use of RWE for those purposes. Further, under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI), FDA committed to publishing draft guidance on how RWE can contribute to the assessment of safety and effectiveness in regulatory submissions. FDA is issuing the draft guidance entitled “Data Standards for Drug and Biological Product Submissions Containing Real-World Data” as part of a series of guidance documents to satisfy the Cures Act mandate and the PDUFA VI commitment.
Data Standards for Drug and Biological Product Submissions Containing Real-World Data: Draft Guidance for Industry https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-drug-and-biological-product-submissions-containing-real-world-data
FR notice inviting comment: https://www.federalregister.gov/documents/2021/10/22/2021-23081/data-standards-for-drug-and-biological-product-submissions-containing-real-world-data-draft-guidance