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Accenture ResearchAccenture Research Agenda Agenda‚ US Overview‚ US PMP Overview‚ PMP Expenditures‚ Regulatory System‚ Pharmaceuticals Overview‚ Medical Products Overview‚ Distributor Overview‚ Key PMP Players‚ US PMP Outlook‚ Appendix22 ¬ 2008 Accenture. All rights reserved. Adhikari,Dawn amp; Melberg - accenture Hamp;LS consultant 23. Accenture ResearchAccenture ResearchThe US Food amp; Drug Administration (FDA) is the primary regulator of the pharmaceutical and medical products industries in the USUS PMP Overview: Regulatory System‚All drugs must be accepted by the FDAprior to being marketed and sold in the US ‚The FDA requires that pharmaceuticalmanufacturers perform extensive testing to US FDAprove that their products are safe andeffective before it will sanction commercialsale ‚New drugs must pass through a three Enforces US foodstage process of Clinical Trials beforeamp; drug lawsreceiving final approval from the FDA ‚The FDA estimates that, of 20 drugsRegulates the Introductionentering clinical trial testing, an average ofof New Drugs Monitors the manufacture,13 to 14 will successfully complete phase I Transport amp; storage of‚ of those only 9 will finish phase II and food, drugs and cosmeticsonly 1 or 2 will pass phase III ‚Due to recent concerns over drug safety,Clinical TrialsThe FDA is working on improving ways totrack the safety of drugs already Phase I Phase II Phase III on the market; Tightening labelrequirements and planning to expand theduties of advisory committees are two New Drug Applicationmeasures currently underway to achieve (NDA)more effective post-market surveillance Source: Pharmaceutical Industry Survey.

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