Ethical Pharmaceuticals:

Links to U.S. Laws and Regulations

New Drug Application (NDA):

21 USC § 355(b)

21 CFR Sub. Ch. D, Pt. 314, Sub. Pt. B, §§ 314.50-314.90

Abbreviated New Drug Application (ANDA):

21 USC § 355(j)

21 CFR Sub. Ch. D, Pt. 314, Sub. Pt. C, §§ 314.92-314.99

Investigational New Drug Application (INDA):

21 USC § 355(i)

21 CFR Sub. Ch. D, Pt. 312, Sub. Pt. B, §§ 312.20-312.38

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