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2. New Drug Application - Wikipedia

   en.wikipedia.org/wiki/New_Drug_Application

   The documentation required in an NDA is supposed to tell "the drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.” [2] Once approval of an NDA is obtained, the new ...

3. Abbreviated New Drug Application - Wikipedia

   en.wikipedia.org/wiki/Abbreviated_New_Drug...

   An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product.

4. Drug Master File - Wikipedia

   en.wikipedia.org/wiki/Drug_Master_File

   In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.

5. Horizon's NDA for Procysbi New Dosage Form Accepted by FDA - AOL

   www.aol.com/news/horizons-nda-procysbi-dosage...

   The FDA accepts Horizon Therapeutics' (HZNP) NDA for Procysbi (Cysteamine Bitartrate) delayed-release oral granules in packets.

6. Non-disclosure agreement - Wikipedia

   en.wikipedia.org/wiki/Non-disclosure_agreement

   A unilateral NDA (sometimes referred to as a one-way NDA) involves two parties where only one party (i.e., the disclosing party) anticipates disclosing certain information to the other party (i.e., the receiving party) and requires that the information be protected from further disclosure for some reason (e.g., maintaining the secrecy necessary to satisfy patent laws [5] or legal protection ...

7. Wikipedia:Non Disclosure - Wikipedia

   en.wikipedia.org/wiki/Wikipedia:Non_Disclosure

   This policy derives from Non-disclosure agreement, called NDA in the following description. Basically an NDA is included into knowledge compilations, for instance intend for commercial, technical work, to ensure production flow. Additional reasons can be means of national security etc.