2007, Pharmacokinetics and Pharmacy - Drug Discovery Digest

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

SEPTEMBER 15, 2023

In 2007, an FDA advisory committee weighed phenylephrine’s GRASE status, prompted by a Citizen Petition questioning its effectiveness In December 2007, the FDA’s Nonprescription Drugs Advisory Committee met to discuss the efficacy of phenylephrine 10 mg , the oral dosage approved for OTC use.

Science

Science FDA Clinical Trials Clinical Pharmacology

Medicare Coverage Analysis Worksheet

Advarra

DECEMBER 14, 2022

Effective as of 2007, Medicare has offered coverage for routine costs in clinical trials. Pharmacy manual. Safety, quality of life, and pharmacokinetic (PK) responses are not considered to be therapeutic objectives. However, in order to be eligible for extended coverage under a clinical trial, several requirements must be met.

Clinical Trials

Clinical Trials Trials Compliance FDA Approval

Drug Discovery Digest

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Medicare Coverage Analysis Worksheet

Webinars

Stay Connected