resources

Links of Interest

Associations and Professional Organizations

Below are links to external websites of associations and professional organizations of interest to pharmacoepidemiologists

 

Food and Drug Administration

  • Food and Drug Administration

  • FDA Medwatch
    MedWatch, the FDA Medical Products Reporting Program, is an initiative designed both to educate all health professionals about the critical importance of being aware of, monitoring for, and reporting adverse events and problems to FDA and/or the manufacturer and; to ensure that new safety information is rapidly communicated to the medical community thereby improving patient care.

    The purpose of the MedWatch program is to enhance the effectiveness of postmarketing surveillance of medical products as they are used in clinical practice and to rapidly identify significant health hazards associated with these products.

    MedWatch has four goals:

    1. To increase awareness of drug and device-induced disease
    2. To clarify what should (and should not) be reported to the agency.
    3. To make it easier to report by operating a single system for health professionals to report adverse events and product problems to the agency.
    4. To provide regular feedback to the health care community about safety issues involving medical products

    ISPE is a MedWatch Partner. ISPE works with the FDA to help keep its members informed about the FDA Medical Products Reporting and Safety Information Program and encourage them to play an active role in postmarketing surveillance.

  • FDA Index to Drug Specific Information
    This Index includes drugs that have been the subject of a Drug Safety Communication, Healthcare Professional Information sheet, Early Communication About an Ongoing Safety Review, or other important information.

  • FDA Guidance, Regulatory and Compliance Information
    Information from the Center for Drug Evaluation and Research branch of the FDA

    Reagan-Udall Foundation for the FDA

    Innovation in Medical Evidence & Development Surveillance

 

Other Governmental Agencies

 

Research Organizations and Networks

 

Online Tools