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  2. 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 ...

  3. Prescription Drug User Fee Act - Wikipedia

    en.wikipedia.org/wiki/Prescription_Drug_User_Fee_Act

    The FDA argued that it needed additional staff to end its back-log of drugs awaiting approval for market. The FDA had not received sufficient appropriations from Congress to hire them. For decades the FDA had asked for permission to implement user fees and the pharmaceutical industry generally opposed them, fearing that the funds would not be ...

  4. Investigational New Drug - Wikipedia

    en.wikipedia.org/wiki/Investigational_new_drug

    If the FDA detects a problem, it may place a clinical hold on the IND, prohibiting the start of the clinical studies until the problem is resolved, as outlined in 21 CFR 312.42. An IND must be labeled "Caution: New Drug – Limited by Federal (or United States) law to investigational use," per 21 CFR 312.6

  5. NDA and business with Saudi royals: Book offers details about ...

    www.aol.com/nda-business-saudi-royals-book...

    Dave McCormick, the GOP candidate who hopes to unseat U.S. Sen. Bob Casey in November, has pointed to his experience as a business leader as evidence that he would make an effective representative ...

  6. Red Dead Redemption 2’s NDA Was Stricter Than Marvel’s - AOL

    www.aol.com/red-dead-redemption-2-nda-143702502.html

    Red Dead 2 cowboy. Actors – in both film and video games – are often bound to secrecy through the use of legal documents called non-disclosure agreements, or NDAs.

  7. 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 ...

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