4. FDA_ClinicalTrialsGov_2.pdf;JSESSIONIDVISTA=L3g8Tj9WclKS4GxXBvwCXM6dmZK1vnmPdCtvqPzw7KYQxxJ2C219

4. FDA_ClinicalTrialsGov_2.pdf;JSESSIONIDVISTA=L3g8Tj9WclKS4GxXBvwCXM6dmZK1vnmPdCtvqPzw7KYQxxJ2C219

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1 David W. Mullis, Jr., Ph.D., RAC www.RA.Rx.UGA.edu ClinicalTrials.gov 2 ClinicalTrials.gov • FDAMA 1997 ClinicalTrials.gov established Entering Clinical Trials was optional • FDAAA 2007 Registering Clinical Trials now required Certification of Compliance required for most FDA submissions Fine for non-compliance is $10,000/day • At any given time, more than 70,000 trials going on worldwide, per ClinicalTrials.gov
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2 3 Source: “A New Era: Clinical Trial Results Open to the Public”; Regulatory Focus ; Oct. 2008. www.ClinicalTrials.gov 4 Reporting Clinical Trial Data (historical outline) Food and Drug Administration Modernization Act of 1997 enacted. Establishes ClinicalTrials.gov website, which becomes operational in Feb. 2000. Entering protocol data is optional. FDA Amendment Act passed Sept. 27, 2007. Entering data into ClinicalTrials.gov is now required. Deadline for entering protocol data for a clinical trial started after Sept. 27, 2007 is 21 days after first subject enrollment.
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3 5 Reporting Clinical Trial Data (cont. historical outline) Certification of Compliance is required for almost all FDA submissions. The fine for non-compliance is $10,000 per day. On Sept. 27, 2008, “basic results” reporting requirements became effective. On Sept. 27, 2009, “adverse events” reporting requirements became effective. 6 Submissions for ClinicalTrials.gov IND (investigational new drug) NDA (new drug application) ANDA (abbreviated new drug application, i.e., a generic drug) BLA (biologic licensing application) PMA (premarket approval for a medical device) HDE (humanitarian device exemption) 510(k) (medical device) PDP (product development protocol) Types of submissions that must be entered into ClinicalTrials.gov:
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4 7 Submissions Not Required for ClinicalTrials.gov Phase 1 study (for drugs or biologics) Small feasibility studies (medical device) Pediatric postmarket surveillance studies (medical device) Clinical trial to test prototype devices where the primary measure relates to feasibility and not to health outcomes (medical device) Types of submissions that are not required to be entered into ClinicalTrials.gov: Source: FDAAA page 121 STAT.904 . 8
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This note was uploaded on 01/01/2012 for the course PHAR 6010 taught by Professor Mullis during the Spring '11 term at University of Georgia Athens.

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4. FDA_ClinicalTrialsGov_2.pdf;JSESSIONIDVISTA=L3g8Tj9WclKS4GxXBvwCXM6dmZK1vnmPdCtvqPzw7KYQxxJ2C219

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