OR WAIT null SECS
June 24, 2016
The agency publishes draft reference material for implementation of FDA’s quality metrics guidance.
June 22, 2016
OPKO’s newly approved extended-release capsule uses Catalent’s OptiShell softgel capsule technology.
The Pharmacopoeial Discussion Group approved monographs and plans to harmonize several others.
The agency cited the company for sterile manufacturing violations.
The two agencies have set up a working group on involving patients in drug development.
June 20, 2016
The assay, co-developed by Grifols and Hologic, will be used to test blood donations in the United States.
Emergent is seeking approval for the manufacture of BioThrax at the company’s large-scale manufacturing facility.
June 16, 2016
The agency provides quality, development, manufacturing, and labeling recommendations.
June 15, 2016
FDA sent a warning letter to The Compounding Pharmacy of America for deficiencies in sterile manufacturing.
June 13, 2016
The agency published guidance on the nonclinical evaluation of osteoporosis treatments.