Blog
RSS FeedPosted by Michael Wonder on 08 Dec 2021
Improvements to clinical trials will strengthen Australia’s economy and benefit patients
8 December 2021 - Clinical trials in Australia need improvements if we are to increase our global competitiveness says Medicines ...
Posted by Michael Wonder on 07 Dec 2021
Remarks by President Biden on prescription drug costs
6 December 2021 - Today, I’d like to talk about how we’re going to help millions of Americans protect and ...
Posted by Michael Wonder on 07 Dec 2021
U.S. plans to fast track revamped COVID-19 vaccines
5 December 2021 - Study from South Africa suggests the fast-spreading Omicron variant might cause less severe illness than its predecessors. ...
Posted by Michael Wonder on 07 Dec 2021
ICMRA high-level meeting on global health emergencies and regulatory approaches
6 December 2021 - On 1 - 2 December, International Coalition of Medicines Regulatory Authorities, a group of leading medicines regulatory ...
Posted by Michael Wonder on 07 Dec 2021
Product approval and public health at the US Food and Drug Administration
6 December 2021 - Since the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act, drug approval in ...
Posted by Michael Wonder on 06 Dec 2021
HCF calls for independent regulator of medical devices
6 December 2021 - Health insurer HCF has raised concerns that some doctors may be deciding what device to implant ...
Posted by Michael Wonder on 04 Dec 2021
Reforms needed for FDA’s regulation of medical devices
3 December 2021 - Medical devices are mainstays of modern medicine, from basic products like gloves and bandages to complex ...
Posted by Michael Wonder on 03 Dec 2021
ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic
3 December 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organisation have reviewed some of ...
Posted by Michael Wonder on 02 Dec 2021
Investors say drug pricing measure may shift incentives for biotech venture funding
2 December 2021 - Some analysts say bill would discourage investment in drugs taken as pills. ...
Posted by Michael Wonder on 02 Dec 2021
Strengthening patient access to new medicines through new landmark Bill
2 December 2021 - Australians will see improved access to new and innovative medicines, vaccines and treatments as a landmark ...
Posted by Michael Wonder on 30 Nov 2021
Updated 2021 – 22 cost recovery implementation statement
30 November 2021 - The 2021-22 Pharmaceutical Benefits Scheme and National Immunisation Plan Cost Recovery Implementation Statement has been updated ...
Posted by Michael Wonder on 29 Nov 2021
Biosimilar industry vets critique Biden's drug pricing reforms
29 November 2021 - Specialty tiers for biosimilars and reforms that address the proliferation of poor quality patents would help ...
Posted by Michael Wonder on 26 Nov 2021
Drug, insulin price caps head for showdown over Senate rules
26 November 2021 - Senate Democrats expect to defend key portions of their drug pricing agenda against a technical challenge ...
Posted by Michael Wonder on 25 Nov 2021
Drugmakers gear up for price restrictions in Biden’s legislative agenda
25 November 2021 - Industry potentially faces significant expansion of government regulation despite success in watering down Democratic proposals. ...
Posted by Michael Wonder on 25 Nov 2021
A divisive ruling on devices — Genus Medical Technologies v. FDA
24 November 2021 - The FDA has long taken the legal position that regulated devices could also be categorised as drugs. ...