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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

268
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
268

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Which Scott Gottlieb will run the FDA?

Merrill Goozner

    Modern Healthcare
    |November 14, 2018
    PubMed
    Summary

    Dr. Scott Gottlieb

    Area of Science:

    • Public Health Policy
    • Regulatory Affairs
    • Medical Ethics

    Background:

    • The Food and Drug Administration (FDA) plays a critical role in public health and drug safety.
    • Nominees to lead the FDA undergo scrutiny regarding potential conflicts of interest.
    • Dr. Scott Gottlieb was nominated to lead the FDA, prompting an examination of his financial ties.

    Purpose of the Study:

    • To investigate the extent of financial conflicts of interest for Dr. Scott Gottlieb during his nomination to lead the Food and Drug Administration.
    • To assess the implications of these financial ties on regulatory impartiality and public trust.

    Main Methods:

    • Review of financial disclosures and investment portfolios of Dr. Scott Gottlieb.
    • Analysis of company affiliations and business dealings relevant to the FDA's regulatory purview.

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  • Quantification of financial gains derived from investments in companies regulated by the FDA.

    • Main Results:

    • Dr. Scott Gottlieb received substantial payments and held investments in numerous companies with business before the FDA.
    • His financial portfolio included dozens of entities directly impacted by FDA decisions.
    • The estimated earnings from these investments amounted to millions of dollars.

    Conclusions:

    • Dr. Scott Gottlieb presented significant financial conflicts of interest upon his nomination for FDA leadership.
    • These conflicts raise concerns about the potential influence of financial interests on regulatory decision-making.
    • The findings underscore the importance of rigorous conflict-of-interest assessments for public health officials.