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BioWorld - Wednesday, June 3, 2026
Home » Authors » Tamra Sami

Articles by Tamra Sami

Industry supportive of TGA priority review intentions, but critical of methods

July 10, 2017
By Tamra Sami

Australia rolls out new priority review, orphan drug pathways

July 3, 2017
By Tamra Sami

PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) will start accepting priority review applications, and it has expanded its orphan drug designation criteria, thanks to new legislation passed last month that overhauls the country's drug regulations.


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Australia rolls out new priority review, orphan drug pathways

July 3, 2017
By Tamra Sami
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) will start accepting priority review applications, and it has expanded its orphan drug designation criteria, thanks to new legislation passed earlier this month that overhauls the country's drug regulations.
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NIH small business grants help de-risk biotech investments and attract more capital

June 23, 2017
By Tamra Sami

NIH grants critical to de-risk programs, attract more capital

June 23, 2017
By Tamra Sami
SAN DIEGO – Recent policy changes are more favorable for small companies looking for startup funds, and the NIH is a good place to start.
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Australia's Senate passes TGA reform bill for drugs, devices

June 20, 2017
By Tamra Sami

PERTH, Australia – Industry stakeholders in Australia welcomed the Senate passage of the drug and device reforms contained in the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 last week.


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Australia's Senate passes new TGA reform for drugs, devices

June 19, 2017
By Tamra Sami

Australia's Senate passes TGA reform bill for drugs, devices

June 19, 2017
By Tamra Sami
PERTH, Australia – Industry stakeholders in Australia welcomed the Senate passage of the drug and device reforms contained in the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 last week.
Read More

Australia will have its own NBs, will accept global regulators' approvals

May 25, 2017
By Tamra Sami

Avita Medical’s Recell spray-on-skin meets endpoints in pivotal trial

May 24, 2017
By Tamra Sami
PERTH, Australia – Avita Medical Ltd. plans to submit its Recell spray-on-skin premarket approval application to the FDA in a few weeks following positive results from its pivotal trial.
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