2016, Clinical Development, Clinical Pharmacology and Pharmacokinetics

Search:

DAY

WEEK

MONTH

YEAR

Select your country:
Sign up | Log in

2016

Clinical Development

Clinical Pharmacology

Pharmacokinetics

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

Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. Four comments were submitted to the docket established for the 2015 Petition.

Science

Science FDA Clinical Trials Pharmacy

Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Agency IQ

DECEMBER 11, 2023

Oncology at FDA in 2023: A quick glance at the numbers First created under the 21st Century Cures Act of 2016 and launched in 2017, FDA’s Oncology Center of Excellence (OCE ) “unites experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies.”

FDA

FDA Science Clinical Trials Trials

Drug Discovery Digest

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

Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Stay Connected