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Table of Contents: Reference Materials
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| A |
7-16-08 FDA NYK-DO API Seminar Presentation Notes |
| B |
FD&C Act 201(g) & (p) [21 USC 321(g) & (p)] Definitions; generally |
| C |
FD&C Act 502(f) & (o) [21 USC 352(f) & (o)] Misbranded drugs and devices |
| D |
FD&C Act 503(b)(1) [21 USC 353(b)(1)] Exemptions and consideration for certain drugs, devices, and biological products |
| E |
FD&C Act 505 [21 USC 355] New Drugs |
| F |
FD&C Act 510(i) [21 USC 360(i)] Registration of producers of drugs or devices |
| G |
FD&C Act 801 [21 USC 381] Imports and Exports |
| H |
FD&C Act 802 [21 USC 382] Exports of certain unapproved products |
| I |
FD&C Act 803 [21 USC 383] Office of International Relations |
| J |
21 CFR § 201 Drugs; adequate directions for use |
| K |
21 CFR § 207.3 Definitions; 207.35 R&L; 207.40 R&L |
| L |
21 CFR § 312.160 Drugs for investigational use in laboratory research animals or in vitro tests |
| M |
CPG 460.200 Pharmacy Compounding Compliance Policy Guides Manual |
| N |
Draft Guidance: E-Registration & Listing: FRN Vol. 73, No. 134, 7/11/08, Page 39964 |
