Australia’s TGA To Stamp Out Clinical Evidence Mistakes By Industry
Executive Summary
The Australian Therapeutic Goods Administration is attempting to clarify its expectations on clinical evidence requirements for medical devices to stop the many errors companies are making in their submissions for market authorization.
You may also be interested in...
Australia’s 'Unrealistic' Randomized Controlled Trial Proposal Comes Under Fire
Industry is not entirely happy with the Therapeutic Goods Administration’s proposed guidelines on clinical evidence requirements.
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Moment Of Truth For Seven EU Filings; Cytokinetics To Make Its Case For Heart Failure Drug
The CHMP, the European Medicines Agency’s human medicines committee, will this week decide whether a range of new medicines merit being approved.