viernes, 10 de febrero de 2017

Abbreviated New Drug Application (ANDA): Generics > Abbreviated New Drug Application (ANDA) Forms and Submission Requirements

Abbreviated New Drug Application (ANDA): Generics > Abbreviated New Drug Application (ANDA) Forms and Submission Requirements



FDA has updated the Model Bioequivalence Data Summary Tables. Applicants are asked to refer to the Clinical Data Interchange Standards Consortium (CDISCfor 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:

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 esub@fda.hhs.gov or the FDA Center for Biologics Evaluation and Research (CBER) at esubprep@cber.fda.govQuestions regarding submission of datasets to CDER may be sent to edata@fda.hhs.gov.

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