IND / NDA / ANDA / BLA

The IND is what makes human testing lawful. Shipping an unapproved drug across state lines is otherwise prohibited, so the IND is the exemption that permits it. It carries the non-clinical safety package, the chemistry and manufacturing information, and the clinical protocol. Filing starts a 30-day clock: unless FDA places the study on clinical hold, dosing may begin once those days elapse.

The marketing applications differ by what evidence they rest on. An NDA (21 CFR 314) supports a new drug with full safety and efficacy data. A 505(b)(2) application is a hybrid — a new drug that relies in part on data the applicant does not own, typically published literature or FDA’s prior findings for a listed drug. An ANDA supports a generic, and substitutes demonstrated bioequivalence to the reference listed drug for independent clinical efficacy trials.

A BLA is the licence application for a biological product under section 351 of the Public Health Service Act rather than the FD&C Act — the legal distinction that also produces biosimilars under 351(k) instead of generics. Whichever route, the application must describe the manufacturing process and controls in detail, and FDA’s pre-approval inspection tests whether the site can actually make what the dossier claims.

• —IND (21 CFR 312) — the exemption that permits human testing; 30-day review clock before dosing may start.
• —NDA (21 CFR 314) — full safety and efficacy data for a new drug.
• —505(b)(2) — a hybrid NDA relying partly on data the applicant does not own.
• —ANDA — a generic; bioequivalence to the reference listed drug replaces independent efficacy trials.
• —BLA — biologics, licensed under PHS Act §351; biosimilars follow the 351(k) pathway.
• —Every route is backed by a pre-approval inspection testing whether the site can make what the dossier describes.

21 CFR Part 312 (IND); 21 CFR Part 314 (NDA and ANDA, including §314.54 for 505(b)(2)); Public Health Service Act §351 with 21 CFR Part 601 (BLA); Federal Food, Drug, and Cosmetic Act §505 and §505(j).