Blog
RSS FeedPosted by Michael Wonder on 14 Dec 2021
FDA publishes discussion paper and seeks public input on 3D printing of medical devices at the point of care
10 December 2021 - Today, the U.S. FDA published a discussion paper regarding 3D printing medical devices at the point of ...
Posted by Michael Wonder on 25 Jul 2021
Patient advocacy organisations and FDA drug approval: lessons from Aduhelm
23 July 2021 - In the wake of last month’s controversial FDA approval of Biogen’s Aduhelm, Alzheimer’s Association CEO Harry ...
Posted by Michael Wonder on 04 Feb 2021
Repurposing of prescription medicines
4 February 2021 - The Therapeutic Goods Administration is conducting a public consultation that seeks to understand potential obstacles and ...
Posted by Michael Wonder on 23 Jun 2020
Submissions received: fees and charges proposal 2020-21
23 June 2020 - On 20 January 2020, the Therapeutic Goods Administration (TGA) released on its website a consultation paper, ...
Posted by Michael Wonder on 08 Apr 2020
Submissions on whether the TGA should publish that a prescription medicine is under evaluation
8 April 2020 - Between 15 February and 29 March 2019, the TGA sought comments from interested parties on the ...
Posted by Michael Wonder on 15 Feb 2019
Whether the TGA should publish that a prescription medicine is under evaluation
15 February 2019 - The TGA is seeking comments from interested parties on whether or not the TGA should in future ...
Posted by Michael Wonder on 05 Feb 2019
Risk classification of antimicrobials used in animals opens for public consultation
5 February 2019 - EMA has published today for public consultation its updated scientific advice on the categorisation of antimicrobials. ...
Posted by Michael Wonder on 15 Nov 2018
EMA seeks feedback on using registries for regulatory purposes
15 November 2018 - The EMA is seeking feedback on the use of patient disease registries for regulatory purposes. ...
Posted by Michael Wonder on 31 Oct 2018
Working with stakeholders to improve availability of medicines in the EU
31 October 2018 - The task force set up by EMA and the Heads of Medicines Agencies on availability of ...
Posted by Michael Wonder on 22 Sep 2018
The FDA announces Patient Engagement Advisory Committee meeting on utilising real world data from patient-driven platforms that connect and empower patients
21 September 2018 - On 15 November 2018, the FDA’s Patient Engagement Advisory Committee will hold its second public meeting ...
Posted by Michael Wonder on 12 Jun 2018
Statement from FDA Commissioner on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making
12 June 2018 - Over the past decade, advances in our understanding of the basic biology of serious and life-threatening ...
Posted by Michael Wonder on 05 Jun 2018
FDA drafts new guidance on formal meetings between FDA, biosimilar sponsors
4 June 2018 - The US FDA has released new draft guidance on formal meetings between biosimilar sponsors and the ...
Posted by Michael Wonder on 09 Apr 2018
Public hearing on 13 June 2018
9 April 2018 - Citizens to be consulted on quinolone and fluoroquinolone antibiotics. ...
Posted by Michael Wonder on 06 Oct 2017
EMA takes yet another step in public engagement with its first public hearing
6 October 2017 - Summary report now published. ...
Posted by Michael Wonder on 06 Sep 2017
Medical devices sponsor information day - 2017
6 September 2017 - TheTGA invites medical device sponsors and their staff to attend the Medical Devices Sponsor Information Day in ...