OR WAIT null SECS
April 03, 2017
Both the European Union and United States are still ironing out issues such as confidentiality of information and recognition of competence of each party’s regulatory authorities in their agreement on GMP inspections.
GW Pharmaceuticals plans to submit a regulatory filing to FDA and EMA following two positive Phase III trials of Epidiolex in patients with Lennox-Gastaut Syndrome.
March 27, 2017
Manufacturers and regulators are working to reach consensus on the harmonization of management of postapproval changes.
March 24, 2017
The agency recommended six drugs for approval in March 2017 including treatments for neuroblastoma, heart failure, and more.
The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs
March 23, 2017
The taskforce will be evaluating how data can be used to support pharmaceutical research, innovation, and development.
March 02, 2017
Efforts to harmonize the fragmented regulatory framework for pharmaceuticals in the European Union continue to be a challenge.
February 24, 2017
The agency’s CHMP recommended six drugs for market approval, including one orphan drug, during its February meeting.
February 15, 2017
The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.
Baricitinib (Olumiant) is the first JAK inhibitor licensed to treat rheumatoid arthritis in Europe.