Issue Date: September 1, 1994
Issued by: Center for Drug Evaluation and Research
Topic(s): Chemistry, Manufacturing, and Controls (CMC), Pharmaceutical Quality
Status: Final
Format and Content for the CMC Section of an Annual Report
To describe the information requested by the Center for Drug Evaluation and Research (CDER) in an Annual Report to a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Abbreviated Antibiotic Application (AADA) submitted pursuant to 21 CFR 314.81(b)(2).
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