Remove 2007 Remove FDA Approval Remove Pharmacokinetics
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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The FDA maintains a webpage with the full rulemaking history for OTC nasal decongestant drug products.

Science 40
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Medicare Coverage Analysis Worksheet

Advarra

Effective as of 2007, Medicare has offered coverage for routine costs in clinical trials. FDA-approved IDE devices may be deemed qualifying under the Medicare Benefit Policy Manual, Chapter 14. Safety, quality of life, and pharmacokinetic (PK) responses are not considered to be therapeutic objectives.

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Making a “Miracle” HIV Medicine

Codon

Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates.