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  1. www.fda.gov › drugs › development-approval-process-drugsDrug Approvals and Databases | FDA - U.S. Food and Drug...

    Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting. Additional topics include: approved REMS, drug shortages, and the...

  2. www.fdatracker.com › fda-calendarFDA Calendar - FDA Tracker

    Our enhanced FDA calendar integrates PDUFA dates, clinical trial primary completion dates, and working capital runway estimates into a single timeline that covers companies publicly traded in the U.S. facing upcoming PDUFA dates.

  3. www.fda.gov › drugsDrugs | FDA - U.S. Food and Drug Administration

    Search our databases: Drugs@FDA. Find information about most FDA-approved prescription, generic, and over-the-counter drug products. Drug Shortages. Find information about drug shortages caused...

  4. www.fda.gov › drugs › information-consumers-and-patients-drugsThe FDA's Drug Review Process: Ensuring Drugs Are Safe and...

    This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. For controlled trials, patients receiving the drug are compared with...

  5. www.fda.gov › drugs › information-consumers-and-patients-drugsFind Information about a Drug | FDA - U.S. Food and Drug...

    9 Αυγ 2022 · Search FDA Approved Drugs on Drugs@FDA. Explore the database to find drug labels (package inserts), generics, patient information, FDA review and approval history.

  6. www.fda.gov › drugs › information-consumers-and-patients-drugsFDA's Drug Review Process: Continued | FDA - U.S. Food and Drug...

    The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug). The FDA inspects the facilities where the drug will be manufactured as part...

  7. www.fda.gov › drugs › drug-approvals-and-databasesAbout Drugs@FDA | FDA - U.S. Food and Drug Administration

    Download Drugs@FDA Express for free. Drugs@FDA includes most of the drug products approved since 1939. The majority of patient information, labels, approval letters, reviews, and other...

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