Blog
RSS FeedPosted 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 16 May 2017
New guidance for patient group partners taking part in SMC Committee meetings
15 May 2017 - From June 2017, the SMC will be introducing new processes to improve how they involve patient ...
Posted by Michael Wonder on 15 May 2017
HTA programme response to the challenges of dealing with orphan medicinal products: process evaluation in selected European countries
15 May 2017 - Challenges commonly encountered in HTA of orphan medicinal products (OMPs) were identified in Advance-HTA. Since then, new ...
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 17 Apr 2017
Expanding CADTH’s drug review processes to include radiopharmaceuticals
17 April 2017 - In collaboration with the participating jurisdictions, CADTH is pleased to announce that it will accept submissions ...
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 25 Feb 2017
The importance of Swiss-style claims in Australia
24 February 2017 - The Federal Court has recently issued a decision that highlights the importance of including Swiss-style claims ...
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 ...
Posted by Michael Wonder on 06 Feb 2017
Medicines evaluation not keeping pace with scientific progress, says ABPI
3 February 2017 - Following the news that a new breast cancer medicine - palbociclib - from Pfizer has been ...
Posted by Michael Wonder on 08 Dec 2016
Single drug technology assessment processes across Health Technology Assessment organisations
8 December 2016 - Health Technology Assessment (HTA) informs health care decision-makers about the value — such as the safety, efficacy, ...
Posted by Michael Wonder on 24 Nov 2016
Updated submission form and guide for Patient Group Partners
24 November 2016 - Following feedback from patient groups and our committee members, the SMC has introduced an updated Patient ...
Posted by Michael Wonder on 21 Nov 2016
Consultation on CADTH’s proposed process for the assessment of companion diagnostics
21 November 2016 - CADTH is inviting stakeholder comments and feedback on the following proposed process for the assessment of companion ...
Posted by Michael Wonder on 22 Oct 2016
Deal or delay: NICE's new negotiating chip
20 October 2016 - With the UK's NHS facing a financial challenge that shows no signs of abating any time ...
Posted by Michael Wonder on 22 Oct 2016
Faster access to drugs
20 October 2016 - Dr Jacoline Bouvy, Scientific Adviser – IMI ADAPT-SMART, discusses how to bring new drugs to patients faster. ...