FDA 21 CFR 314: Application for FDA Approval to Market a New Drug
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21 CFR 314 contains the procedures and requirements for FDA submission and review of applications and abbreviated applications to market new drugs. It also contains the procedures and requirements for amendments, supplements, and post-marketing reports.ﾠ
The section most commonly cited in software related deficiencies is 21 CFR 314.80(c), requirements for reportingﾠ post-marketing adverse drug experiences.ﾠ
| Issuing Body | FDA Regulations |
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