FDA Filing for Drugs 

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States.

Type II DMF contains information on a Single Drug Substance, Drug Substance Intermediate, Material Used in the Preparation of the Drug, and Drug Product. The holder must describe all steps involved in the manufacturing of the drug under discussion.

An abbreviated new drug application (ANDA) contains data that is submitted to the FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower-cost alternative to the brand-name drug it references. A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics, and intended use.

A 505(b)(2) application is an NDA that contains full reports of investigations of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant, and for which the applicant has not obtained a right of reference or use, including, for example, the Agency’s finding of safety and/or effectiveness for a listed drug or published literature. NDAs requiring full reports of investigations of safety and effectiveness that were conducted by or for the applicant, or for which the applicant has a right of reference or use, known as “stand-alone” NDAs, are submitted under section 505(b)(1) of the FD&C Act.

An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Clinical studies are often conducted to collect safety and effectiveness information in support of marketing applications for biologic and drug products. Unless exempted, the sponsor for a clinical study must obtain authorization from FDA for conduct the study by submitting an IND Application. Such authorization must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics Product License Application.

For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization.  The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.  The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.

eCTD or electronic common technical document filing is a mandatory requirement for all regulatory submissions. It is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).