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October 23, 2015
The excipient supplier's cGMP practices have been certified as meeting EXCiPACT standards
October 16, 2015
FDA issued a warning letter to API manufacturer Unimark Remedies Ltd. for cGMP violations at its facility in India.
October 13, 2015
The European Medicines Agency plans on using existing patient registries to collect information on medicines.
October 06, 2015
The agency provides recommendations for submitting proposed labeling with abbreviated new drug applications.
October 02, 2015
FDA selected USDM Life Sciences, RC Partners, and The Clarion Group to develop and implement a DSCSA pilot project.
September 28, 2015
The agency releases guidance on the use of pharmacokinetics and pharmacodynamics analyses in the development of antibiotics.
The agency releases guidance on controlled correspondences related to generic-drug development.
September 16, 2015
The White House nominates Robert Califf to head FDA, but will he be confirmed?
Polydrug Laboratories is issued a US import alert, following similar bans in Canada and Europe.
FDA issues warning letter to Jaychem Industries, Auckland, New Zealand for violating CGMP regulations.