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Aggregate reporting, also known as periodic reporting, plays a key role in the safety assessment of drugs. Aggregate reporting involves the compilation of safety data for a drug over a prolonged period of time (months or years), as opposed to single-case reporting which, by definition, involves only individual AE reports.
The aims of RADAR are to disseminate safety reports for serious adverse drug reactions (sADRs) and to identify barriers to identification and reporting of these clinical events. Investigators have developed a well-coordinated system to accurately compile case report information on sADRs and to identify milestones associated with identification ...
The most recent reauthorization will further expand on the previous policy. It aims to broaden and upgrade the drug safety program, allocate more resources for television advertising, and theoretically allow the FDA to more efficiently review and approve safe and effective new drugs for consumers. [4]
Since drugs and medical devices are approved on the basis of clinical trials, which involve relatively small numbers of people who have been selected for this purpose – meaning that they normally do not have other medical conditions which may exist in the general population – postmarketing surveillance can further refine, or confirm or deny ...
The information is packaged into aggregate reports and then sold to businesses, as well as to local, state, and government agencies. This information can also be useful for marketing purposes. In the United States, many data brokers' activities fall under the Fair Credit Reporting Act (FCRA) which regulates consumer reporting agencies .
(Reuters) - The U.S. FDA is ramping up its investigation of the clinical trials that tested an MDMA-based therapy, the Wall Street Journal reported on Friday, citing people familiar with the matter.
Patient safety work product includes any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements (or copies of any of this material), which are assembled or developed by a provider for reporting to a PSO and are reported to a PSO; or are developed by a patient safety organization for the conduct ...
The FDA determines as part of the drug approvals process that a REMS is necessary, and the drug company develops and maintains the individual program. [2] REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. REMS for generic drugs may be created in collaboration with the manufacture of the brand name ...