New Drug Approvals

DECEMBER 24, 2023

2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] 7 March 2023. Archived from the original on 26 September 2023. Retrieved 21 December 2023 – via PR Newswire. February 2023). October 2023). S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The committee also made recommendations regarding pharmacokinetic and safety assessments.

Science 40

Science FDA Clinical Trials Pharmacy 40

Agency IQ

DECEMBER 1, 2023

Revisions to this guidance reflect both the growing body of knowledge related to Covid-19 and some subtle shifts in FDA policy over the past few years. In January 2023, the White House announced that the federal Covid-19 national emergency and PHE would officially end on May 11, 2023.

FDA 40

FDA Clinical Trials Vaccine Trials 40