Regulatory

Jun 27, 2018
By BioPharm International Editors
FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data.
Jun 14, 2018
By BioPharm International Editors
FDA Commissioner Scott Gottlieb, MD, released a statement on new agency efforts to involve the patient voice in medical product development and FDA regulatory decision-making.
Jun 01, 2018
BioPharm International
FDA and Congress seek to limit the production and distribution of pain medicines.
May 14, 2018
By BioPharm International Editors
Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.
May 10, 2018
By BioPharm International Editors
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
By BioPharm International Editors
The company received a complete response letter from FDA in response to the biologics license application for a proposed rituximab biosimilar.
May 07, 2018
By BioPharm International Editors
The data and analytics company reports on the anticipated uptake of Humira (adalimumab)‎‎ biosimilars in the EU once they are launched in 2018.
May 07, 2018
Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.
Apr 24, 2018
By BioPharm International Editors
EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.
Apr 19, 2018
By BioPharm International Editors
The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.
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