USFDA issued MAPP on NDAs and BLAs: Communication to Applicants of Planned Review Timelines.
This MAPP established procedures for informing applicants of the planned review timeline, including the goal dates for discussion of labeling and post-marketing authorization requirements (PMRs) and commitments (PMCs), for original new drug applications (NDAs), Biologic Licensing Application (BLAs), and efficacy supplements submitted to the Center for Drug Evaluation and Research (CDER).
Click the link for detailed manual of policies and procedures.
This MAPP established procedures for informing applicants of the planned review timeline, including the goal dates for discussion of labeling and post-marketing authorization requirements (PMRs) and commitments (PMCs), for original new drug applications (NDAs), Biologic Licensing Application (BLAs), and efficacy supplements submitted to the Center for Drug Evaluation and Research (CDER).
Click the link for detailed manual of policies and procedures.
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