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September 09, 2014
Roche?s RoACTEMRA receives EU approval for use in patients with early rheumatoid arthritis.
August 07, 2014
The European system for assessing drugs will be used as a model internationally.
July 10, 2014
The European Medicine Agency details the agency?s recommendations for drug-marketing authorizations for the first half of 2014.
FDA clarifies GDUFA requirements in regards to abbreviated new drug applications and prior approval supplements.
July 01, 2014
FDA releases guidance documents and rules on requirements for compounding human drug products.
European Medicines Agency clarifies advanced-therapy medicinal products classification.
June 17, 2014
FDA provides advice to supply-chain stakeholders on how to identify suspect drug products and how to notify the agency of those products.
June 12, 2014
EMA has published a new guidance template for the qualified person’s declaration concerning GMP compliance of API manufacture. The QP declaration template provides the basis for demonstrating compliance of the API manufacture with GMP requirements and ensures that the manufacturer has sufficient knowledge on the supply chain.
Draft guidance from FDA includes information essential for the completion of ANDA applications.
June 06, 2014
Despite GMP deficiencies, EMA reinstates GMP certificate for Ranbaxy's Toansa facility, citing no threat to public health.