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The History of Biologics Regulation | FDA - U.S. Food …

    https://www.fda.gov/about-fda/fda-history/history-biologics-regulation
    Modern federal oversight of biological products began under the 1902 Biologics Control Act, which the Hygienic Laboratory of the Public Health and Marine Hospital Service carried out. With the...

Biopharmaceutical - Wikipedia

    https://en.wikipedia.org/wiki/Biopharmaceutical

    Milestones in U.S. Food and Drug Law | FDA

      https://www.fda.gov/about-fda/fda-history/milestones-us-food-and-drug-law
      Federal controls over the drug supply began with inspection of imported drugs in 1848, although the first federal biologics law, which addressed the provision of …

    Biologics: The pricey drugs transforming …

      https://theconversation.com/biologics-the-pricey-drugs-transforming-medicine-80258
      The Biologics Control Act, passed in 1902, was the first law aimed at ensuring the safety of some of the earliest biologics – vaccines. Congress was moved to …

    The Evolution Of Biologic Drugs – IPac …

      https://ipaction.org/blog/the-evolution-of-biologic-drugs/
      While biologics are one of the fastest-growing drug categories in the U.S., they aren’t exactly new. The …

    The History of Drug Regulation | FDA

      https://www.fda.gov/about-fda/fda-history/history-drug-regulation
      The History of Drug Regulation Federal regulation of drugs emerged as early as 1848, under a law that addressed only imported drugs. In 1905 the American Medical …

    Biological Approvals by Year | FDA - U.S. Food and …

      https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biological-approvals-year
      See the Development and Approval Process page for a description of what types of products are regulated at Biologics License Applications (BLAs), Premarket …

    How biologics have changed the rules for …

      https://www.chemistryworld.com/molecule-to-market/how-biologics-have-changed-the-rules-for-pharma/3010301.article
      There’s been a lot of hype about the advent of biological medicines (biologics) since they first emerged in the 1980s. Already, they are providing real benefits for patients with …

    Top 10 Biologic Drugs in the United States

      https://www.verywellhealth.com/top-biologic-drugs-2663233
      It's currently co-marketed in the United States by Biogen Idec and Roche subsidiary Genentech. Rituxan is approved for: Non-Hodgkin's lymphoma; Chronic …

    Biosimilars in the United States 2020–2024

      https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2020-2024
      The current biologics market of $211 billion can be segmented into 19% of the market, or $40 billion, already facing some biosimilar competition, 64% or $135 …



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