Included in the CARES Act are long-awaited reforms to the FDA’s regulation of over-the-counter (OTC) medications. H.R. 748, §§ 3851-3862. The FDA has hailed the law as granting it “transformative, new ...
Move away from the cumbersome current monograph finalization process to an administrative order procedure. Additional processes will be in place to ensure recourse should issues arise; Create new ...
Some wines get better with age, but regulatory systems typically do not. In general, a process that worked in 1972 doesn’t necessarily work as well in 2018. Such is the case with the regulatory system ...
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