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  2. Novartis - Wikipedia

    en.wikipedia.org/wiki/Novartis

    Novartis AG is a publicly traded Swiss holding company that operates through the Novartis Group and owns, directly or indirectly, all companies worldwide that operate as subsidiaries of the Novartis Group. [110] Novartis's businesses are divided into two operating divisions: Innovative Medicines and Sandoz (generics). [111]

  3. Regulatory affairs - Wikipedia

    en.wikipedia.org/wiki/Regulatory_affairs

    Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance.. It is a position mostly found within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare ...

  4. Novartis Gene Therapies - Wikipedia

    en.wikipedia.org/wiki/Novartis_Gene_Therapies

    Novartis Gene Therapies, until 2020 known as AveXis, is a biotechnology company that develops treatments for rare neurological genetic disorders. It was founded in Dallas , Texas , United States in 2012 by John Carbona after reorganizing a company called BioLife Cell Bank founded by David Genecov and John Harkey.

  5. MedDRA - Wikipedia

    en.wikipedia.org/wiki/MedDRA

    A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing ...

  6. America’s Most Admired Lawbreaker - The Huffington Post

    highline.huffingtonpost.com/miracleindustry/...

    On January 5, Lisa Stockbridge of the FDA’s Division of Drug Marketing, Advertising and Communications wrote to Janssen’s director of regulatory affairs complaining that “presentations that focus on this population are misleading in that they imply that the drug has been found to be specifically effective in the elderly population.

  7. Regulatory agency - Wikipedia

    en.wikipedia.org/wiki/Regulatory_agency

    A regulatory agency (regulatory body, regulator) or independent agency (independent regulatory agency) is a government authority that is responsible for exercising autonomous jurisdiction over some area of human activity in a licensing and regulating capacity.

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