Eye on FDA

AUGUST 4, 2021

FDA has had its reputation tested not only by that decision but by the events of the past few years that called into question a possible politicization of the process and all of the misinformation around COVID-19 and vaccinations. The most active of these committees with vacancies this year has been the Oncologic Drugs Advisory Committee.

FDA 122

FDA Clinical Pharmacology FDA Approval Therapies 122

Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

Pharma Companies 111

Pharma Companies Licensing Licensing Disease 111

The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. Advances in artificial intelligence, machine learning, large datasets, and CM&S technologies are assisting the pharmaceutical industry in the drug development process.

Drug Development 52

Drug Development Disease Clinical Trials Drugs 52

Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER.

FDA 52

FDA Biosimilars Science Drugs 52

Eye on FDA

JANUARY 5, 2022

Of note, this tally does not include meetings of the Vaccines and Related Biologic Products Advisory Committee held to consider a recommendation for COVID-19 vaccines, but includes only drugs and biologics. FDA Adcomms have been declining in number even as the agency approves more drugs.

FDA 76

FDA Clinical Pharmacology Vaccine Production 76

The Pharma Data

OCTOBER 15, 2020

formed a Partnership Advisory Committee comprised of former multi-national pharmaceutical veterans and industry leaders. Prior to that role, Hanna served as CEO at ORIC Pharmaceuticals and before that, Hanna was head of Commercial and Medical Affairs Finance at Genentech and CFO of the Genentech Foundation.

Pharmaceuticals 52

Pharmaceuticals Clinical Pharmacology Medical Schools Therapies 52

Agency IQ

JUNE 2, 2023

Start Date End Date Event Event Type Center 06/05/2023 06/09/2023 Regulatory Education for Industry (REdI) Annual Conference 2023 Virtual CDER 06/07/2023 06/08/2023 Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for Rare Disease Drug Development Public CDER 06/07/2023 06/08/2023 RDEA Pilot Program 2023 Public Workshop Workshop (..)

FDA 40

FDA Science Regulations Production 40