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.
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The Australian government plans to introduce a series of regulatory reforms for devices and drugs over a period of three years, including moves to speed up access to innovative devices and to better leverage assessments by overseas regulators. The changes may include some recovery of costs from industry.
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.
Oral explanation meetings are due to take place this week for drug sponsors who have a final chance to address questions and concerns the European Medicines Agency has about their marketing applications.