Drug Experience Report

Keller, W.C., Bataller, N. and Oeller, D.S. (1998). Processing and evaluation of adverse drug experience reports at the Food and Drug Administration Center for Veterinary Medicine. 

Periodic adverse experiences reports These reports must be submitted quarterly for the first 3 years after approval of the product (within 30 days of the end of the quarter) and annually (within 60 days of the anniversary of the approval date) thereafter. Periodic adverse drug experience reports should present a narrative overview and discussion of the safety information received during the reporting period. 

Johnson, M., 6c Barash, D. (1991). A review of postmarketing adverse drug experience reporting requirements. Food, Drug, and Cosmetic Law Journal, 46, 665-672. 

Postmarketing reports of adverse drug experience, including the 15-day alert reports and the periodic drug experience reports, should be submitted, unbound, in duplicate, to ... 

Officials at the FDA Bureau of Medicines debated this dilemma It has been found that if the case-reporting format is sufficiently comprehensive to include all of the items which are desired, it becomes so involved that cooperation and interest in the reporting of individual cases will rapidly diminish. 38 As a compromise, they devised a Drug Experience Report that combined key elements of the AM A reporting form with concerns that had arisen in the early 1960s. 

Esch, A. Food and Drug Administration Drug Experience Reporting System. Journal of Chemical Documentation 9 (May 1969) 66-70. 

FD 3 500A Form Used to Submit Drug Experience Report... 

In the United States, adverse reaction reporting for veterinary pharmaceuticals is conducted under a programme operated by the Center for Veterinary Medicine (CVM), which is part of the US Food and Drug Administration (FDA). The FDA provides cumulative veterinary adverse drug experience reports (currently 1987 to 30 April 2012) on its website (http //www.fda.gov/ AnimalVeterinary/default.htm). These reports cover adverse drug reaction... 

With these limitations in mind, it is useful to examine the adverse drug experience reports in humans for the period 1987 to 2012. These are shown in Table 15.2. It is evident from this table that injection site injuries are relatively... 

While brain serotonin systems may play a key role in mediating some of the effects of MDMA on analgesia and body temperature as well as in the reported anxiolytic-like and mood-altering subjective effects of the drug, additional neurotransmitter systems may contribute to some of the unique subjective experiences reported for MDMA and other drugs in this class. 

See also CFR Web site, http //www.access.gpo.gov/nara/cfr/index.html. An August 1997 guideline, Post-Marketing Adverse Experience Reporting for Human Drug and Licensed Biological Products Clarification of What to Report, defined the minimum data relevant for a safety report as... 

The number on the outside of the case is required to be numeric or alphanumeric, not the name of the patient. Patient names are not permitted to be publicly disclosed in the context of a MedWatch report according to 21 CFR 21.63(f). The initial report is the first reported information received by the company about an individual s adverse drug experience. There must be a prompt attempt to obtain follow-up information about each initial report. The attempt(s) are made according to the company s written procedures. If the written safety procedures are not followed, the safety reports are not appropriately submitted, or the safety records are not appropriately kept, FDA has the authority under Section 80 of Part 315 to withdraw the market NDA. The follow-up report is the format for submitting additional information about an experience. Each case regards only one individual unless the experience is both temporally and clinically unrelated to a second event experienced by the same person taking the same drug product. 

Postmarketing adverse drug experiences are reported to a drug company by the public via regulatory authorities, literature, attorneys, consumers, and health... 

The FDA IND regulations contain requirements for various types of records and reports, which must be adhered to without exception. Immediate reports to FDA are required for any serious and unexpected adverse experience associated with the drug. Annual reports are required for every IND. Records must be kept to document all aspects of the IND. 

Although 2-PAM is an FDA-approved drug, data submitted to the FDA to obtain approval are proprietary and were not released when requests for them were made to the FDA and to the manufacturer. A report of the FDA Adverse Drug Experiences Monitoring Program (October 30, 1983) contained one adverse reaction (hypotension following 1 g by intravenous Injection). 

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