Blog
RSS FeedPosted by Michael Wonder on 07 Sep 2022
FDA accepts Integral Molecular's letter of intent on membrane proteome array antibody specificity test into ISTAND drug development tools pilot program
7 September 2022 - Integral Molecular has been accepted into the US FDA's ISTAND pilot program. ...
Posted by Michael Wonder on 30 Jul 2019
Reforms to the generic medicine market authorisation process
30 July 2019 - The TGA would like to thank respondents who provided submissions in response to the public consultation ...
Posted by Michael Wonder on 23 Jan 2018
Using health technology assessment to assess the value of new medicines: results of a systematic review and expert consultation across eight European countries
23 January 2018 - Although health technology assessment systems base their decision making process either on economic evaluations or comparative clinical ...
Posted by Michael Wonder on 01 Dec 2017
FDA aims to expand early approval program for promising drugs
30 November 2017 - Scott Gottlieb speaks before House subcommittee on health. ...
Posted by Michael Wonder on 15 Nov 2017
FDA unveils a streamlined path for the authorisation of tumour profiling tests alongside its latest product action
15 November 2017 - The U.S. FDA today authorised Memorial Sloan Kettering Cancer Center’s IMPACT (Integrated Mutation Profiling of Actionable Cancer ...
Posted by Michael Wonder on 20 Oct 2017
New action plan to foster development of advanced therapies
20 October 2017 - Actions address specific challenges identified by stakeholders. ...
Posted by Michael Wonder on 04 Oct 2017
Countdown to launch of new EudraVigilance system
4 October 2017 - Final preparations for change-over to new system underway for go live date on 22 November 2017 ...
Posted by Michael Wonder on 29 Sep 2017
FDA improves access to reports of adverse drug reactions
28 September 2017 - New online tool makes it easier for users to search the FDA Adverse Event Reporting System. ...
Posted by Michael Wonder on 01 Sep 2017
Provisional approval pathway for prescription medicines
1 September 2017 - The TGA would like to thank respondents who provided submissions in response to the March 2017 ...
Posted by Michael Wonder on 26 Jun 2017
Priority review pathway: prescription medicines
26 June 2017 - As part of the Government's response to the Review of Medicines and Medical Devices Regulation (MMDR review), ...
Posted by Michael Wonder on 23 May 2017
New FDA pathway to accelerate development of cell therapies
22 May 2017 - Four products have already qualified for the regenerative medicine advanced therapy designation that provides extra interactions with ...
Posted by Michael Wonder on 04 May 2017
FDA and NIH release final template for clinical trial protocols
2 May 2017 - A little more than a year ago, FDA and NIH announced the availability of a draft template ...
Posted by Michael Wonder on 02 Mar 2017
'Burdensome' FDA drug approval process fuels innovation, saves lives
28 February 2017 - I watched two speeches today that shared a common drug topic but with opposing philosophies. ...
Posted by Michael Wonder on 01 Mar 2017
Trump derides ‘slow and burdensome’ approval process at FDA
28 February 2017 - President Trump on Tuesday called on the FDA to speed the approval of drugs to treat ...
Posted by Michael Wonder on 13 Feb 2017
Grassley launches inquiry into orphan drugs after KHN investigation
10 February 2017 - Republican Sen. Chuck Grassley, chairman of the Senate Judiciary Committee, has opened an inquiry into potential ...