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March 19, 2014
Looking to improve patient access to new medicines, EMA creates a pilot project to explore an adaptive licensing approach with real medicines in development.
March 06, 2014
Agencies extend successful pilot program to further harmonization of QbD topics.
March 04, 2014
New guidance from FDA asks for documentation of CMC postapproval manufacturing changes.
March 02, 2014
Manufacturers are taking measures to comply with new package safety rules.
China's regulatory and compliance environment is set to change as the government declares a crackdown on bribery scandals.
February 27, 2014
Discovery of split and broken tablets led to drug recalls.
February 25, 2014
FDA revises interpretation of the five-year NCE exclusivity provisions for certain fixed-combination drug products.
February 11, 2014
EMA releases an update on its flu vaccine guidance.
EMA and the European Commission revise Q&A document on implementation of marketing authorization guidelines.
February 05, 2014
The Food and Drug Administration plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.