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May 10, 2018
The agency is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for violating cGMP requirements.
May 08, 2018
The company received a complete response letter from FDA in response to the biologics license application for a proposed rituximab biosimilar.
May 07, 2018
Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.
Pharmaceutical companies should consider what is required for QIDP designation and whether they can use it to extend the protection afforded to their innovative products.
The data and analytics company reports on the anticipated uptake of Humira (adalimumab) biosimilars in the EU once they are launched in 2018.
May 02, 2018
The European Union is collaborating with the Pharmaceutical Inspection Co-operation Scheme to develop similar guides for evaluating inspectorates’ competency.
Updated guidelines and new technologies aid visual inspection of parenteral products and packaging.
Public health authorities and the biomedical research community are seeking new strategies to address global health threats.
FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.
Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.