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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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This article addresses pricing and reimbursement challenges associated with clinical utilization of approved gene therapies. The authors recommend potential approaches to resolve these challenges, the implementation of which may help solve issues related to the high cost of these therapies and encourage continued innovation and further development of advanced gene therapies.
This article discusses recent changes to Australia's Orphan Drug Program, including eligibility criteria as well as the designation process for applications and limits on the designation period. Preliminary review of the first eight months indicates the number of designations has reduced significantly.
Expanded access, also referred to as compassionate use, is a vital pathway for patients with life-threatening diseases to gain early access to unapproved investigational medical devices. This article summarizes expanded access programs for medical devices in the US, Europe, Japan, Canada and Australia.
The US Food and Drug Administration (FDA) on Thursday issued guidance to be implemented immediately on the submission of study datasets in developing vaccines.
This article discusses issues and efforts related to expanded access programs aimed at providing patients with quicker access to new and experimental drugs, many of which are potentially lifesaving. The perspectives of health authorities, industry and patients are explored as well as the historical legal and ethical issues involved in ensuring expanded access drugs are safe and efficacious.
Regulatory Focus newsletters
All the biggest regulatory news and happenings.
