Blog
RSS FeedPosted by Michael Wonder on 11 Sep 2017
How the EU regulates medicines
11 September 2017 - Awareness session for international regulators and NGOs on the work of EMA and European medicines regulatory ...
Posted by Michael Wonder on 07 Sep 2017
Statement from FDA Commissioner Scott Gottlieb on a new qualified health claim advising that early introduction of peanuts to certain high-risk infants may reduce risk of peanut allergy
7 September 2017 - As the science governing allergies and diets continues to evolve, so do expert recommendations around how best ...
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 06 Sep 2017
Patent term extensions in Australia: under pressure but safe for now
6 September 2017 - Government responds to the Productivity Commission Report and the Courts find “Swiss-style” claims not sufficient for ...
Posted by Michael Wonder on 06 Sep 2017
We may soon learn just how flexible Scott Gottlieb's FDA is
6 September 2017 - One the FDA's biggest controversies is coming back to test its new leadership. ...
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 ...
Posted by Michael Wonder on 05 Sep 2017
Interoperability: FDA’s final guidance on smart, safe, medical device interactions
5 September 2017 - Imagine an intensive care unit for newborns. An interface on a device called a pulse oximeter is ...
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 31 Aug 2017
Statement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda in multiple myeloma
31 August 2017 - Clinical trials play a critically important role in bringing to market innovative new therapies for patients ...
Posted by Michael Wonder on 28 Aug 2017
Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine
28 August 2017 - One of the most promising new fields of science and medicine is the area of cell therapies ...
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 24 Aug 2017
FDA, EMA and EC sign new confidentiality commitment
24 August 2017 - The US FDA can now share non-public and commercially confidential information, including trade secrets relating to ...
Posted by Michael Wonder on 24 Aug 2017
Multidimensional evidence generation and FDA regulatory decision making
22 August 2017 - Evidence linking interventions with health outcomes is the basis for good health care decision making. ...
Posted by Michael Wonder on 23 Aug 2017
Strengthening EU-US cooperation in medicine inspections
23 August 2017 - New commitment allows FDA to share full inspection reports with European Commission and EMA ...