Blog
RSS FeedPosted by Michael Wonder on 18 Nov 2017
U.S. FDA extends review for Tlando; Advisory Committee meeting date of 10 January 2018 remains unchanged
17 November 2017 - Lipocine today announced the U.S. FDA has extended the review period for the new drug application ...
Posted by Michael Wonder on 17 Oct 2017
EMA’s procedural handling of safety review was complete and independent
17 October 2017 - European Ombudsman concludes her inquiry into the HPV vaccines referral. ...
Posted by Michael Wonder on 13 Oct 2017
A ‘holy cow’ moment: the FDA approved a record number of generics
12 October 2017 - As the FDA attempts to foster more competition in the prescription drug market, the agency appears ...
Posted by Michael Wonder on 12 Oct 2017
Product Information
12 October 2017 - Changes make critical clinical information easier to find. ...
Posted by Michael Wonder on 04 Oct 2017
Expanded access: FDA describes efforts to ease application process
3 October 2017 - FDA has a long history of supporting patient access to investigational new treatments. ...
Posted by Michael Wonder on 04 Oct 2017
EMA publishes comments on Member States’ hosting bids
3 October 2017 - Accessibility for delegates and experts and staff retention are key to ensure Agency’s ability to function ...
Posted by Michael Wonder on 07 Sep 2017
FDA’s plan to engage the public in the agency’s new effort to strengthen and modernise FDA’s regulatory framework
7 September 2017 - We’re at a moment of extraordinary opportunity to improve the public health. New innovations are giving us ...
Posted by Michael Wonder on 07 Sep 2017
Drug makers push back on data requirements in Australia’s provisional approval pathway
5 September 2017 - A who’s who of leading drug makers have raised concerns about the proposed data requirements for ...
Posted by Michael Wonder on 28 Aug 2017
Statement on Government’s response to Productivity Commission’s inquiry in intellectual property
25 August 2017 - Medicines Australia notes the Government has today released their response to the Productivity Commission’s Inquiry in ...
Posted by Michael Wonder on 16 Aug 2017
Flimsy evidence behind many FDA approvals
16 August 2017 - Many drugs granted accelerated approval by the U.S. FDA lack clear evidence of safety and effectiveness, ...
Posted by Michael Wonder on 15 Aug 2017
Characteristics of pre-approval and post-approval studies for drugs granted accelerated approval by the US Food and Drug Administration
15 August 2017 - The FDA granted accelerated approval to 22 drugs for 24 indications. ...
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 ...
Posted by Michael Wonder on 01 Jun 2017
Health policy trials
31 May 2017 - Clinical trials are most commonly associated with drugs and devices, but there are notable examples of trials ...
Posted by Michael Wonder on 01 Jun 2017
Swissmedic touts 2016 performance: 42 new approvals
30 May 2017 - In its annual report released Tuesday, Swiss drug regulator Swissmedic says it outpaced the EMA and ...
Posted by Michael Wonder on 07 May 2017
Conditional approval of medicines by the EMA
2 May 2017 - The process fails to improve the evidence after early licensing. ...