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Home » Authors » Tamra Sami

Articles by Tamra Sami

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.
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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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Avita Medical's Recell spray-on-skin meets co-primary endpoints in pivotal burn trial

May 22, 2017
By Tamra Sami

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

May 22, 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.
Read More

Australian Senate committee sides with industry on list of pricing reform goals

May 19, 2017
By Tamra Sami

Aussie drug and device companies laud budget's commitment to innovation

May 11, 2017
By Tamra Sami

R&D tax incentive unscathed: Aussie firms laud federal budget

May 11, 2017
By Tamra Sami
PERTH, Australia – Australia's biopharma and medical device industries breathed a collective sigh of relief that the Australian Government's 2017 budget announced May 9 left the much-loved R&D tax incentive untouched.
Read More

TGA proposes stiffer penalties, compliance tools in exchange for earlier product access

May 10, 2017
By Tamra Sami
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