Regulation Text
Authority
21 U.S.C. 321,331,351,352,353,355,355a,355f,356,356a,356b,356c,356e,360cc,360ddd,360ddd-1,371,374,379e,379k-1.
Related Guidelines (10)
Referencing Approved Drug Products in ANDA Submissions Guidance for Industry (Status: Final)
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→Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies: Draft Guidance for Industry (Status: Draft)
→Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs (Status: Final)
→PET Drug Applications - Content and Format for NDAs and ANDAs: Attachment I: Sample formats for chemistry, manufacturing, and controls (CMC) sections_2011 (Status: Final)
→Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for Industry (Status: Final)
→Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry (Status: Draft)
→Orange Book Questions and Answers Guidance for Industry: Guidance for Industry (Status: Final)
→Changes to Disposable Manufacturing Materials: Questions and Answers Guidance for Industry (Status: Final)
→Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA (Status: Final)
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