RegulatoryGlossary Term
An application submitted to the FDA requesting permission to administer an investigational drug or biological product to humans in clinical trials in the United States.
The Investigational New Drug application represents the regulatory gateway to human clinical trials in the United States, providing the FDA with information necessary to evaluate whether proposed studies are reasonably safe for initial administration to humans. Before any clinical investigation of a new drug can begin, federal law requires that an IND be in effect, establishing a regulatory framework that protects trial participants while enabling the development of promising new therapies.
The IND submission must contain three principal categories of information. The Chemistry, Manufacturing, and Controls section describes the drug substance and drug product, including composition, manufacturing process, stability data, and quality controls. The Pharmacology and Toxicology section presents preclinical studies demonstrating that the drug is reasonably safe for initial human testing at the proposed doses. The Clinical section includes the protocol for initial human studies, qualifications of investigators, and the Investigator's Brochure summarizing all available information about the drug.
The FDA review process operates under a 30-day review clock, during which the agency evaluates whether the proposed studies expose subjects to unreasonable risk. If no clinical hold is issued during this period, the sponsor may proceed with the proposed studies. The IND remains in effect throughout clinical development, with sponsors required to submit protocol amendments before initiating new studies, safety reports when significant adverse events occur, annual reports summarizing development progress, and information amendments providing new chemistry or pharmacology data. This ongoing communication ensures continued regulatory oversight as development progresses.
Initial IND submission
"The sponsor submitted the IND application containing three months of stability data, completed toxicology studies, and the Phase I protocol, and proceeded with first-in-human dosing after the 30-day FDA review period elapsed without a clinical hold."
IND amendment
"Before initiating the Phase II study, the sponsor submitted a protocol amendment to the IND, providing the revised protocol, updated Investigator Brochure, and information on the new clinical sites."
A premarket submission to the FDA demonstrating that a medical device is substantially equivalent to a legally marketed predicate device and therefore does not require premarket approval.
An FDA pathway allowing approval of drugs for serious conditions based on a surrogate endpoint or intermediate clinical endpoint reasonably likely to predict clinical benefit, with post-marketing requirements to confirm the expected benefit.
A regulatory submission to the FDA requesting approval to market a biological product in the United States, demonstrating that the product meets standards for safety, purity, and potency.
An FDA program for drugs intended to treat serious conditions where preliminary clinical evidence indicates substantial improvement over available therapies on clinically significant endpoints.
An FDA program designed to expedite the development and review of drugs intended to treat serious conditions and fill an unmet medical need, providing increased communication with FDA and eligibility for Rolling Review.
An application submitted to the FDA requesting permission to administer an investigational drug or biological product to humans in clinical trials in the United States.
The Investigational New Drug application represents the regulatory gateway to human clinical trials in the United States, providing the FDA with information necessary to evaluate whether proposed studies are reasonably safe for initial administration to humans. Before any clinical investigation of a new drug can begin, federal law requires that an IND be in effect, establishing a regulatory framework that protects trial participants while enabling the development of promising new therapies.
The IND submission must contain three principal categories of information. The Chemistry, Manufacturing, and Controls section describes the drug substance and drug product, including composition, manufacturing process, stability data, and quality controls. The Pharmacology and Toxicology section presents preclinical studies demonstrating that the drug is reasonably safe for initial human testing at the proposed doses. The Clinical section includes the protocol for initial human studies, qualifications of investigators, and the Investigator's Brochure summarizing all available information about the drug.
The FDA review process operates under a 30-day review clock, during which the agency evaluates whether the proposed studies expose subjects to unreasonable risk. If no clinical hold is issued during this period, the sponsor may proceed with the proposed studies. The IND remains in effect throughout clinical development, with sponsors required to submit protocol amendments before initiating new studies, safety reports when significant adverse events occur, annual reports summarizing development progress, and information amendments providing new chemistry or pharmacology data. This ongoing communication ensures continued regulatory oversight as development progresses.
Initial IND submission
"The sponsor submitted the IND application containing three months of stability data, completed toxicology studies, and the Phase I protocol, and proceeded with first-in-human dosing after the 30-day FDA review period elapsed without a clinical hold."
IND amendment
"Before initiating the Phase II study, the sponsor submitted a protocol amendment to the IND, providing the revised protocol, updated Investigator Brochure, and information on the new clinical sites."
A premarket submission to the FDA demonstrating that a medical device is substantially equivalent to a legally marketed predicate device and therefore does not require premarket approval.
An FDA pathway allowing approval of drugs for serious conditions based on a surrogate endpoint or intermediate clinical endpoint reasonably likely to predict clinical benefit, with post-marketing requirements to confirm the expected benefit.
A regulatory submission to the FDA requesting approval to market a biological product in the United States, demonstrating that the product meets standards for safety, purity, and potency.
An FDA program for drugs intended to treat serious conditions where preliminary clinical evidence indicates substantial improvement over available therapies on clinically significant endpoints.
An FDA program designed to expedite the development and review of drugs intended to treat serious conditions and fill an unmet medical need, providing increased communication with FDA and eligibility for Rolling Review.