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January 21, 2020
The agency’s joint Big Data Task Force and the Heads of Medicines Agencies proposed actions for the use of big data to support innovation and public health.
January 17, 2020
FDA sent a warning letter to Health Pharma USA after an inspection found the company’s quality unit was not properly overseeing its drug manufacturing operations.
January 16, 2020
The drug is formulated to improve cardiac contractility with a reduced effect on heart rate, blood pressure, and myocardial oxygen consumption while potentially avoiding adverse events associated with current inotrope therapies.
FDA has granted fast track designation for Novavax’s NanoFlu, a recombinant quadrivalent flu vaccine, for use by adults age 65 years and older.
January 14, 2020
Top of CDER’s to-do list for 2020 is tracking adverse events more effectively and combating the opioid crisis.
January 13, 2020
Can a commitment to limit prices to ensure patient access to important new medicines regain public trust and confidence in the biopharmaceutical industry?
The approval comes after the results of a clinical trial that showed 61% of patients had a response lasting six months or longer.
January 10, 2020
The approval was based on successful data from a years-long trial that assessed patient’s tumor status every 12 or 24 weeks for up to 24 months.
January 03, 2020
The numbers of new molecular entities approved in 2019 are close to or exceed FDA’s performance in most previous years.
The agency sent a warning letter to Henan Kangdi Medical Devices Co. Ltd after an inspection found CGMP violations that included a variety of failures of the company’s quality unit.