Remove 2018 Remove Clinical Pharmacology Remove Marketing Remove Regulations
article thumbnail

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

Agency IQ

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 FDA will follow these procedures for both agency-initiated operations (e.g., billion for pseudoephedrine.

Science 40
article thumbnail

XPhyto Secures Exclusive Psychedelic Drug Development Agreement

The Pharma Data

On August 20, 2018, the Company signed the Exclusive Dealing Agreement with Prof. He is also a current member of the Health Canada Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology and the Scientific Advisory Panel on Opioid Analgesic Abuse. XPhyto Therapeutics Corp. ON BEHALF OF THE BOARD.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Janssen Presents Results from Phase 3 ACIS

The Pharma Data

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. FDA on February 8, 2018. [vi] In post marketing experience, QT prolongation, and torsades de pointes have been observed in patients who develop hypokalemia while taking ZYTIGA ®.

article thumbnail

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.