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Lecture slides - 1 Post Drug Approval Process Resource...

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Unformatted text preview: 8/23/2011 1 Post Drug Approval Process Resource: FDA’s Center for Drug Evaluation and Research www.FDA.gov/Drugs PHAR 6010 Important Acronyms* • SRS Spontaneous Reporting System • ICH International Conference on Harmonization • DPE Office of Surveillance & Epidemiology • ADR Adverse Drug Reaction • ADE Adverse Drug Event • TIACC Therapeutic Inequivalency Action Committee • DDMAC Division of Drug Marketing, Advertising & Communications • NDA New Drug Application • ANDA Abbreviated New Drug Application • AADA Abbreviated New Antibiotic New Drug Application • OPDRA Office of Post-marketing Drug Risk Assessment *Order of occurrence in presentation 2 8/23/2011 2 Post Drug Approval Activities • A vital part of CDER's mission is to monitor the safety and effectiveness of drugs that are currently available to the American people • The following topics provide an overview of how CDER works to assure the ongoing safety and effectiveness of drug products currently marketed in the United States 3 Post-Marketing Surveillance • Goal of CDER’s Post Marketing Surveillance System: to monitor the ongoing safety of marketed drugs • This is accomplished by: reassessing drug risks based on new data learned after drug is marketed recommending ways to most appropriately manage that risk 4 8/23/2011 3 Post-Marketing Surveillance • These are done through a variety of activities and tools outlined below: PMS Information Sources Chart MedWatch Spontaneous Reporting System Pharmacoepidemiology Contracts/Cooperative Agreements • This work is accomplished primarily through CDER’s Office of Surveillance & Epidemiology 5 Post-Marketing Surveillance Office of Surveillance and Epidemiology consists of three divisions: • Division of Drug Risk Evaluation primary role is to detect and assess safety signals for all marketed drug products epidemiologists review epidemiologic study protocols that are increasingly required of manufacturers as phase four commitments evaluate various post-marketing surveillance tools that may be incorporated into risk management strategies, such as patient registries and restricted distribution systems 6 8/23/2011 4 Post Marketing Surveillance Office of Surveillance and Epidemiology consists of three divisions: • Division of Medication Errors & Technical Support o provides pre-marketing reviews of all proprietary names, labels and labeling in CDER in order to reduce the medication error potential of a proposed product o provides post-marketing review and analysis of all medication errors CDER receives 7 Post-Marketing Surveillance Office of Surveillance and Epidemiology consists of three divisions: • Division of Surveillance, Research & Communication Support handles risk communication, and outcomes and effectiveness research components of drug safety risk management programs oversees MedWatch, risk communication research and activities such as Medications Guides, Patient Packet Inserts, and pharmacy information surveys 8 8/23/2011...
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This note was uploaded on 01/01/2012 for the course PHRM 7230 taught by Professor Tackett during the Spring '11 term at UGA.

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Lecture slides - 1 Post Drug Approval Process Resource...

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