OR WAIT null SECS
December 12, 2019
According to a consent decree of permanent injunction issued in September 2019, the health and wellness companies must recall and stop distributing products until the companies comply with the Federal Food, Drug, and Cosmetic Act and other requirements included in the consent decree.
The biologic is a novel bone builder that has a dual effect of increasing bone formation and reducing bone loss.
December 06, 2019
The app, CURE ID, is designed to allow the clinical community to report their experiences treating infectious diseases with novel uses of existing FDA-approved drugs.
The agency has approved three applications for generic versions of Gilenya (fingolimod), Novartis’ blockbuster multiple sclerosis drug.
December 05, 2019
FDA’s Office of New Drugs restricting aims to improve scientific exchange and information sharing among review professionals.
December 02, 2019
A NASEM report stresses the importance of information sharing by biopharma companies and cooperation among regulatory authorities.
Regulators are facing huge challenges on how to deal with the digitalization transformation occurring in the healthcare and pharmaceutical sectors.
November 26, 2019
The agency sent warning letters to 15 companies for illegally selling cannabidiol products.
November 21, 2019
The agency sent a warning letter to Torrent Pharma after an inspection found violations of current good manufacturing practices that included a failure to thoroughly investigate batch failures.
November 20, 2019
The guidance provides recommendations for the development and quality information that should be included in NDA and ANDA applications.