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Regulated Product Submission (RPS) is a Health Level Seven (HL7) standard designed to facilitate the processing and review of regulated product information. [1] RPS is being developed in response to performance goals that the U.S. Food and Drug Administration (FDA) is to achieve by 2012, as outlined in the Prescription Drug User Fee Act (PDUFA). [2]
SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).
In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
Submissions must be mailed in. Published materials are paid a rate of $20 per page. (Note: The Antioch Review is currently on hiatus as it deals with the effects of the pandemic. Check for updates ...
However, even during any free trial or other promotion, you will still be responsible for any purchases and surcharges incurred using your account and any sub- or linked-accounts. We reserve the right to limit you to one free trial or promotion of a fee-based Service and to prohibit the combining of free trials, promotions, and other offers.
Data for the submission must include those from one or more rigorous clinical trials. [ 5 ] Due to the plural "adequate and well-controlled investigations" in the statute, FDA has interpreted the substantial evidence requirement as requiring at least two adequate and well-controlled clinical trials, each convincing on its own.
A forced free trial is a direct-marketing technique, usually for goods sold by regular subscription, in which potential buyers are sent a number of free product sample, usually periodic publications. Often, publishers distribute free copies and the reader is not asked to subscribe.
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