FDA has updated the Model Bioequivalence Data Summary Tables. Applicants are asked to refer to the Clinical Data Interchange Standards Consortium (CDISC) for submitting electronic datasets including Plasma Concentration Data, PK Parameter Data, and other applicable data domains for abbreviated new drug application (ANDA) submissions.
The Study Data Standards Resources available on FDA.gov include:
- FDA’s December 2014 final guidance on study data standards, Providing Regulatory Submissions in Electronic Format—Standardized Study Data
- Relevant technical specifications such as:
- “Electronic Submission Requirements for ANDAs: Are You Ready?” Webinar
Under section 745A(a) of the Food, Drug & Cosmetic Act, separate Agency-wide guidances specify the electronic formats, subject matter, and scope of applicability for certain submissions, including submissions to ANDAs. As these are finalized guidances and subject to described timetables for implementation, these guidances are binding and the electronic format(s) specified in that guidance must be used for submissions to ANDAs.
Questions and general information regarding the preparation of submissions in electronic format may be directed to the FDA Center for Drug Evaluation and Research (CDER) at firstname.lastname@example.org or the FDA Center for Biologics Evaluation and Research (CBER) at email@example.com.
Questions regarding submission of datasets to CDER may be sent to firstname.lastname@example.org.