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BioWorld - Wednesday, June 17, 2026
Home » Topics » Regulatory » TGA

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Regulatory front for Jan. 28, 2021

Jan. 28, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Krishnamoorthi eyes ventilator contract; TGA fines company for failure to provide masks; U.S. PPE hoarder indicted; CAP supports Defense Production Act; South African variant in U.S.; GAO: More needs to be done to respond to COVID-19; Biden orders review of scientific-integrity policies.
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Green approved stamp

Pfizer vaccine receives provisional approval in Australia

Jan. 26, 2021
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Pfizer Australia Pty Ltd. for its COVID-19 vaccine, branded Comirnaty, making it the first COVID-19 vaccine to receive approval in Australia.
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Regulatory front for Jan. 26, 2021

Jan. 26, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Epigenomics out in Medicare NCD for CRC screening; TGA tweaks registration process for class I goods; Global initiative to take on Alzheimer’s; More on EMA cyberattack.
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Green approved stamp

Pfizer vaccine receives provisional approval in Australia

Jan. 25, 2021
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Pfizer Australia Pty Ltd. for its COVID-19 vaccine, branded Comirnaty, making it the first COVID-19 vaccine to receive approval in Australia.
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Regulatory front for Jan. 13, 2021

Jan. 13, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: New test beats biopsy for transplant rejection; NICE eyes digital health HTAs; MHRA moves on the hazards of bedrails; TGA zeroes in on tests for COVID-19; HHS posts rule for agency enforcement action.
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Flag of Australia, sky background

Australia’s TGA approves Orthocell’s Celgro regenerative collagen medical device

Jan. 6, 2021
By Tamra Sami
PERTH, Australia – Perth-based regenerative medicine company Orthocell Ltd. received marketing clearance from Australia’s Therapeutic Goods Administration (TGA) for its Celgro collagen medical device for dental guided bone and soft tissue regeneration applications. The approval validates the Celgro platform technology and clears the way for further approvals in nerve and tendon repair, Orthocell CEO Paul Anderson told BioWorld.
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Australia and coronavirus

COVID-19 disrupted Australia’s business but the TGA still met its goals

Jan. 5, 2021
By Tamra Sami
PERTH, Australia – The COVID-19 pandemic certainly put pressure on Australia’s Therapeutic Goods Administration during the 2019 to 2020 year, but it also showed that the agency was able to rise to challenge and not buckle under pressure.
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Glass globe

2020 Year in Review: Rescission of U.S. FDA regulation of lab-developed tests broke new ground

Dec. 31, 2020
By Mark McCarty
As is the case with many national governments, the U.S. federal government does not routinely measure its activities in the calendar year, but we at BioWorld don’t share that outlook. CY 2020 was odd in more ways than one from a regulatory standpoint, and thus we offer our version of a regulatory top 10 for a year that might not look much better in the rear-view mirror than it has looked as a current event.
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Australia and coronavirus

COVID-19 disrupted Australia’s business but the TGA still met its goals

Dec. 31, 2020
By Tamra Sami
PERTH, Australia – The COVID-19 pandemic certainly put pressure on Australia’s Therapeutic Goods Administration during the 2019 to 2020 year, but it also showed that the agency was able to rise to challenge and not buckle under pressure, revealing a number of strengths that the agency will build upon, the TGA said in its annual performance report.
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Regulatory front

Senators sound off on E&M offsets

Dec. 9, 2020
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USPTO finalizes SAS rule, U.S. senators press case for permanent telehealth, CMS no fan of national coverage policy for Allomap, TGA posts guidance for class I tests, Marburg MCMs protected under PREP.
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