Blog
RSS FeedPosted by Michael Wonder on 06 Jul 2017
Brexit must not disrupt drug R&D, say pharma chiefs
6 July 2017 - Industry lobbying began shortly after British referendum last June. ...
Posted by Michael Wonder on 05 Jul 2017
Call for inquiry into medical devices
5 July 2017 - The medical device industry is facing calls for a royal commission as a class action over vaginal ...
Posted by Michael Wonder on 04 Jul 2017
Cost recovery implementation statement 2017-18
4 July 2017 - This Cost Recovery Implementation Statement provides information on how the TGA implements cost recovery activities associated with ...
Posted by Michael Wonder on 04 Jul 2017
Are drug regulators really too slow?
29 June 2017 - Regulators are often accused of delaying approval of new drugs by slow processes. Tom Marciniak and ...
Posted by Michael Wonder on 04 Jul 2017
EMA and EUnetHTA step up interaction to align data requirements
4 July 2017 - A new joint platform for parallel consultation will provide advice to medicine developers and facilitate access ...
Posted by Michael Wonder on 04 Jul 2017
Post-Brexit EU drug regulation deal urged by ministers
4 July 2017 - The UK will continue to co-operate with the European Union on medicine testing after it leaves ...
Posted by Michael Wonder on 03 Jul 2017
Authorised prescribers
3 July 2017 - The Government accepted the Expert Review of Medicines and Medical Devices Regulation recommendation to make changes ...
Posted by Michael Wonder on 03 Jul 2017
Special Access Scheme
3 July 2017 - Introduction of category C pathway and new decision tool. ...
Posted by Michael Wonder on 29 Jun 2017
FDA unveils plan to eliminate orphan designation backlog
29 June 2017 - Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing ...
Posted by Michael Wonder on 28 Jun 2017
FDA commissioner takes on Martin Shkreli-wannabes over huge drug price hikes
28 June 2017 - "We don't play a role in drug pricing, but we do affect drug competition," Dr. Scott Gottlieb ...
Posted by Michael Wonder on 28 Jun 2017
Decision on EMA relocation set for November, council agrees on bidding procedure
23 June 2017 - At the EU Summit in Brussels on Thursday, the European Council backed a procedure to determine ...
Posted by Michael Wonder on 28 Jun 2017
J&J, Medtronic push back against TGA priority review proposal
21 June 2017 - Johnson & Johnson and Medtronic are pushing back against the Australian TGA’s proposed priority review pathway ...
Posted by Michael Wonder on 27 Jun 2017
FDA tackles drug competition to improve patient access
27 June 2017 - Agency takes important steps under new Drug Competition Action Plan. ...
Posted by Michael Wonder on 27 Jun 2017
The medicines and health products that failed Therapeutic Goods Association testing
26 June 2017 - Dodgy vitamins, contaminated medicines, a flu vaccine that didn't work, ineffective hospital disinfectant and unreliable pregnancy ...
Posted by Michael Wonder on 26 Jun 2017
Orphan drug program reforms
26 June 2017 - The objective of the orphan drug program is to provide an incentive to sponsors to bring ...