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April 30, 2018
The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.
April 24, 2018
EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.
April 20, 2018
A federal judge from the Eastern District of Arkansas entered into a consent decree with Cantrell Drug Company.
FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.
April 19, 2018
The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.
April 16, 2018
A new report gives an overview of the work of the International API Inspection Program.
April 12, 2018
The Parenteral Drug Association’s Data Integrity Task Force helps industry members understand regulatory requirements for data integrity.
April 11, 2018
FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.
April 09, 2018
Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.
April 04, 2018
A new book by Robert Thomas, principal consultant at Scientific Solutions, provides a training tool for novices and inexperienced users of plasma spectrochemistry as well as for supervisors and senior management who want to better understand the analytical issues. Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide, published on Feb.