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March 04, 2014
New guidance from FDA asks for documentation of CMC postapproval manufacturing changes.
March 02, 2014
Using best practices for manual or automatic inspection can improve the inspection process.
The root cause of drug shortages is mismanagement of variation.
February 25, 2014
FDA revises interpretation of the five-year NCE exclusivity provisions for certain fixed-combination drug products.
Daiichi Sankyo announced suspension of API shipments from Ranbaxy's Toansa and Dewas plants; issues apology to stakeholders.
February 19, 2014
USP's revised Chapters 41 and 1251, which became official in December 2013, have new requirements for weighing, including balance calibration and testing.
February 11, 2014
EMA releases an update on its flu vaccine guidance.
February 06, 2014
In first official visit to India, FDA commissioner to discuss ongoing collaboration on drug programs.
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.
February 02, 2014
ISPE and PDA take on the challenge of recommending quality metrics.