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Policy controversy

Big PharmaAtlas

Health & Medicine · Pharmaceutical industry

Competing accounts of whether drug companies steer the FDA and the medicine people get, versus imperfect but still independent public oversight, without offering treatment guidance.

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Sources

20 links · 4 cited in evidence

  • 1.FDA PDUFA overviewfda.govCited in evidence
  • 2.GAO review touching FDA capacity/oversightgao.govCited in evidence
  • 3.BMJ piece on pharmaceutical influence and regulationbmj.comCited in evidence
  • 4.EMA funding governanceema.europa.euCited in evidence
  • 5.Prescription Drug User Fee Act Reauthorization (PDUFA VI), Medical Device User Fee Act Reauthorization (MDUFA IV), Generic Drug User Fee Act Reauthorization (GDUFA II), and Biosimilar User Fee Act Reauthorization (BsUFA II) - 03/21/2017 | FDAfda.gov
  • 6.The Prescription Drug User Fee Act: Much More Than User Feespmc.ncbi.nlm.nih.gov
  • 7.Pharmaceutical industry sponsorship and research outcome and quality: systematic reviewpmc.ncbi.nlm.nih.gov
  • 8.Pharma compliance solutions and regulatory success Compliance Insights - Global Relayglobalrelay.com
  • 9.Prescription Drug User Fee Act - Wikipediaen.wikipedia.org
  • 10.Testimony on Prescription Drug User Fee Act (PDUFA) - Public Citizencitizen.org
  • 11.Policy Primers Prescription Drug User Fee Act (PDUFA) - EveryLife Foundation for Rare Diseaseseverylifefoundation.org
  • 12.Prescription Drug User Fee Acten-academic.com
  • 13.Prescription Drug User Fee Act (PDUFA) Explained: How FDA User Fees Work and Why They Matteryoutube.com
  • 14.The Prescription Drug User Fee Act: Good, Bad, or a Lot of Both?pharmacytimes.com
  • 15.Navigating the Complex World of Pharma Regulatory Compliance: Finding the Sweet Spot Between Safety & Innovation | GMP Prosgmppros.com
  • 16.pharmaceutical regulatory capture – The Oklahoma Posttheokpost.com
  • 17.Faster regulatory submissions for pharma with AImckinsey.com
  • 18.A person in a dark suit with a striped tie is adjusting their cufflinks in front of a modern staircase, with text indicating a focus on pharmaceutical regulatory capture and regulatory affairs.i.ytimg.com
  • 19.The image features a presentation slide titled "Drug Regulatory Affairs" with the subtitle "DMF (Drug Master File)," authored by SSM, a professional with 27 years of pharma industry experience.i.ytimg.com
  • 20.The image compares megatrends such as digital transformation and increased autonomy with regulatory affairs trends like AI leverages, global e-submissions, real-world evidence, and diversity emphasis, highlighting how these shifts influence pharmaceutical regulatory capture.frontiersin.org

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