Overview of the FDA Amendments Act of 2007: Its Effect on the Drug Development Landscape
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Overview of the FDA Amendments Act of 2007: Its Effect on the Drug Development Landscape
Roi Kishore, PhD Senior Director, Global Regulatory Strategy. Quintiles Consulting. Rockville, Maryland
Edword kbor, MD Vice President, Global Regulatory Strategy, Quintiles Consulting, Rockville. Maryland
The Food and Drug Administration Amendments Ad of 2007 has improved the transparency of the clinical drug development landscape in the United States in many ways. Some of the important changes require: (a) increased public disclosure of information on clinical trials both while being conducted and during the subsequent public disclosure of the results of the trial; (b) changes to the required labeling including the development of a Risk Evaluation and Mitigation Strategy (REMS) to ensure
Key Words FDAAA; Clinical trials; REMS; Drug safely; Labeling
Corrrrpo~derceAddress Raj Kishore. Senior Director, Global Regulatory Strategy. Quintiles Consulting. I801 Rockville Pike, Suite 300, Rockville. MD 20852 (email: raj.kishore@ quintilescom).
INTRODUCTION On September 27. 2007. President Bush signed the Food and Drug Administration Amendments Act (FDAAA) of 2007 (1). This act reauthorized and extended many of the provisions of the Food, Drug, and Cosmetic Act (FD&C Act) that were about to expire, including those that had been added by the Prescription Drug User Fee Act (PDUFA), the Pediatric Research Equity Act, and the Best Pharmaceuticals for Children Act. It also expanded the requirements for registration of clinical trials and clinical trial data on the website ClinicalTrials.gov, enhanced FDA's authority regarding postmarketing safety evaluation, and provided for a number of other enhancements of FDA's programs for regulating drug development. This article summarizes the provisions of FDAAA that will affect the drug development landscape.
NEW REQUIREMENTS FOR REGISTRATION OF CLINICAL TRIALS Prior to FDAAA, only clinical trials for the treatment or prevention of serious and life-threatening diseases, as well as those supported by certain government grants, were required to be listed in the database maintained by the National Library of Medicine at ClinicalTrials.gov (2).' The database had been created to provide
that the benefits of the product outweigh its risks in the target population; (c) a requirement
to do additional drug safety studies when indicated based on the available safety data; and (d) a requirement for the performance of pediatric studies when the drug may have a potential to provide better treatment options for pediatric subjects and subsequent revision of the labeling based on pediatric studies. lke act has also increased FDA's authority to mandate necessary changes.
information to patients and physicians about ongoing clinical trials. FDAAA broadened the filing requirement to include all clinical trials of drugs, biologics, and devices that are submitted to FDA, except for phase 1 studies. Information about the existence and design of the trials must now be submitted to the database within 21 day
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