An Abbreviated New Drug Application (ANDA) is a regulatory submission that a pharmaceutical company must submit to the U.S. Food and Drug Administration (FDA) to obtain approval for a generic drug.

Unlike a New Drug Application (NDA) which is required for new drugs, an ANDA is submitted for a generic version of a drug that has already been approved by the FDA. The ANDA must demonstrate that the generic drug is equivalent to the reference-listed drug (RLD) in terms of safety, efficacy, and quality.

The ANDA must include data and information on the drug's chemistry, manufacturing, and controls, as well as bioequivalence studies that demonstrate the drug is absorbed into the bloodstream at the same rate and to the same extent as the RLD.

Investigational New Drugs (INDs) are regulatory submissions that a pharmaceutical company must submit to the U.S. Food and Drug Administration (FDA) to conduct clinical trials of a new drug in humans.

An IND includes data and information about the drug's chemistry, manufacturing, and controls, as well as preclinical data and information from animal studies. The submission also includes a detailed plan for the clinical trials, including the study design, the number of patients to be enrolled, and the endpoints to be measured.

The FDA reviews the IND and provides feedback to the pharmaceutical company. If the FDA allows the clinical trial to proceed, the pharmaceutical company can begin testing the drug in humans.

A Drug Master File (DMF) is a regulatory submission that contains confidential information about the manufacturing, processing, packaging, and storing of a drug product or its components. The DMF is submitted to the U.S. Food and Drug Administration (FDA) by a drug manufacturer or supplier.

The DMF is used by the FDA to review information about a drug product or its components without revealing the information to the public. The information in the DMF can be used to support a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA) submitted by another company.

The DMF can include information on the drug substance, drug product, analytical methods, packaging materials, and stability data. The DMF is not a substitute for an NDA, ANDA, or BLA but rather is a supplement to these applications.

The DMF system is designed to help streamline the drug approval process by allowing multiple companies to reference the same information about a drug product or its components. This reduces the burden on drug manufacturers and helps ensure that the FDA has access to all necessary information to make informed decisions about drug approval and safety.