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January 11, 2018
The European Commission has approved AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.
January 05, 2018
FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval.
January 03, 2018
The agency published draft guidance on good practices for submitting abbreviated new drug applications.
January 02, 2018
The authors offer recommendations for permissible daily exposures and concentration limits of elemental impurities for dermal drug products.
Enterprise-wide processes, procedures, and systems are the keys to data integrity and peace of mind, according to Siegfried Schmitt, PhD, principal consultant at PAREXEL.
Process validation is an extension of biologics development processes.
Pharmaceutical companies and contract manufacturing organizations report lack of readiness for the US Drug Supply Chain Security Act serialization deadline.
A review of 2017 advancements from the Open-SCS working group with Charlie Gifford, group technical director.
Everyone may not be ready for the deadline, but open standards based on GAMP and GS1 will soon be released; more companies are also leveraging what they’ve learned from serialization to improve overall efficiency.
December 28, 2017
The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.