Fast Track Archives - PharmaLive

Is Your Quality Management System Ready for Fast Tracked Pandemic Related Drug Approvals?

Business, Coronavirus Disease (COVID-19) Pandemic, COVID-19 Therapeutics, Current Goods and Manufacturing Practice (CGMP), Data, Fast Track, FDA, Investigational New Drug (INDs) submissions, IQVIA, Manufacturing, Medicines, New Drug Applications, New Drug Approvals, R&D, Virtual, Warning Letters

Mike Hidock, Director of Quality and Compliance Services at IQVIA, analyzes key considerations for preparing quality management systems (QMS) for fast tracked COVID-19 treatment approvals.

October 4, 2021/by Andrew Humphreys

FDA commissioner willing to fast-track Covid-19 vaccine: FT

Clinical Trials, COVID-19 Vaccines, Donald Trump, Emergency Use Authorization, Fast Track, FDA Commissioner, FDA/Regulatory, Financial Times, R&D

The head of the U.S. Food and Drug Administration is willing to fast-track a Covid-19 vaccine as quickly as possible, the Financial Times reported him as saying in a published interview.

August 30, 2020/by Andrew Humphreys

Corbus Pharmaceuticals’ Investigational Drug Resunab Granted Fast Track Status by the U.S. FDA for the Treatment of Systemic Sclerosis

Fast Track, FDA/Regulatory, Health, R&D, Systemic Sclerosis

NORWOOD, MA–(Marketwired – Aug 19, 2015) – Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical stage drug development company targeting rare, chronic, and serious inflammatory and […]

August 19, 2015/by Marketwired

Novartis Heart Failure Drug Gains Speedy FDA Approval

Approvals, Cardiovascular, Fast Track, FDA/Regulatory, Health, Heart Failure, Pricing, Priority Review, Therapeutics

Entresto, Novartis’s novel heart failure (HF) drug, gained FDA approval earlier today. The approval arrived six weeks ahead of the drug’s action date. Formerly known as LCZ 696, the drug had already received […]

July 7, 2015/by Forbes Health