21 CFR Subpart B
Administrative Procedures
June 25, 2020
§
330.14
Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded
§
330.15
Timelines for FDA review and action on time and extent applications and safety and effectiveness data submissions
§
330.11
NDA deviations from applicable monograph
§
330.12
Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI)
§
330.13
Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC drug review
§
330.10
Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs
Tried the LawStack mobile app?
Join thousands and try LawStack mobile for FREE today.
- Carry the law offline, wherever you go.
- Download CFR, USC, rules, and state law to your mobile device.
