GRP’s were developed as guidance’s for review staff or as manuals of policies and procedures (MAPPs). An example of GRP is MAPP 6010.3 Rev.1 Good Review Practice: Clinical Review Template. This is a standard clinical review template describing the format and content of a new drug application review. GRP policies are updated regularly as advances are being made in science, statutes update, regulations change, and accumulated experience are gathered.
GRPs are developed over time as superior practices based on CDER’s collective experience to provide consistency to the overall review process of new products. GRPs are developed to improve the quality of reviews and review management. GRPs improve efficiency, clarity, and transparency of the review process and review management. GRPs are expected to be adopted by review staff as standard processes through supervisor mentoring, implementation teams, and formal training when necessary.
GRPs fundamental values are quality, efficiency, clarity, transparency and consistency.
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The line is old and never made sense in the first place, but politician after politician like to extol the fear that if they legalize cannabis, everyone will become a pothead. As it turns out, study after study say the opposite, that legalizations don’t increase cannabis use, particularly in younger populations. Take a look. Yet […]
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All eyes are on Switzerland as the country makes big moves to start its own cannabis industry. The country announced plans for a recreational measure last year, and now Switzerland is introducing a wide-reaching medical program that goes far beyond its previous limits. Switzerland is on a rampage, both widening its medical cannabis program, and […]
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The psychedelics industry is gearing up for a massive debut, and opinions on the compounds are changing for the better. How popular are psychedelics in America right now? New survey results show that these compounds are not unknown to the American public, and that close to 30% of respondents, have already tried them. With the […]
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