EMA Official Dismisses Claims That Prescribers & Companies Won’t Play By Adaptive Pathways Rules
Executive Summary
The “glass is half full,” the European Medicines Agency’s senior medical officer says of efforts to get everyone onboard the adaptive pathways approach for accelerating the approval of drugs for high unmet needs.
You may also be interested in...
New EU Filings
Beremagene geperpavec, Krystal Biotech’s topical, redosable gene therapy for treating dystrophic epidermolysis bullosa, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
EMA To Address Challenges Of Using Organ-On-Chip Models In Drug Development
Microphysiological systems such as organ-on-chip models could not only improve the translational success of drug candidates into the clinic, but also impact the 3Rs in non-clinical safety testing, according to the European Medicines Agency.
French Regulator At Odds With EMA Over Safety Restrictions For Pseudoephedrine
The product information for all pseudoephedrine-containing medicines in the EU will need to be updated, the European Medicines Agency said.