Blog
RSS FeedPosted by Michael Wonder on 16 Aug 2018
Statement from FDA Commissioner on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans
16 August 2018 - Over the last several years, there’s been growing scientific and public interest in the role of microorganisms ...
Posted by Michael Wonder on 01 Aug 2018
FDA supports critical research to spur innovation for continuous manufacturing technology to support and advance drug and biologics development
1 August 2018 - We know that novel manufacturing technologies for both small-molecule drugs and biological products have great potential to ...
Posted by Michael Wonder on 06 Jun 2018
Big pharma wants to invest more in Australian biotech says Greg Hunt
6 June 2018 - Big pharma is "looking at Australia as the next destination in the developed world, the emerging first-world ...
Posted by Michael Wonder on 06 Jun 2018
FDA’s new efforts to advance biotechnology innovation
6 June 2018 - Scientific advances in biotechnology, such as genome editing and synthetic biology, hold enormous potential to improve human ...
Posted by Michael Wonder on 05 Jun 2018
Embracing competition to empower biosimilars
5 June 2018 - In 2017, there were 46 new novel drug innovations, including new treatments for cancers, Parkinson’s disease, ...
Posted by Michael Wonder on 30 May 2018
As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion
30 May 2018 - Agency will work closely with selected applicants to accelerate product development. ...
Posted by Michael Wonder on 11 Apr 2018
Breakthrough-therapy designation — an FDA perspective
12 April 2018 - Recent medical advances, such as targeted therapies for specific tumour genomic defects, checkpoint inhibitors for cancers, and ...
Posted by Michael Wonder on 08 Mar 2018
Balancing safety and innovation for cell-based regenerative medicine
8 March 2018 - Regenerative medicine is a field that involves replacing, engineering, or regenerating human cells, tissues, or organs to ...
Posted by Michael Wonder on 13 Feb 2018
Statement from FDA Commissioner Scott Gottlieb on Administration’s request for new FDA funding to promote innovation and broaden patient access through competition
13 February 2018 - Additional resources will help advance initiatives to support novel medical technology and public health priorities such as ...
Posted by Michael Wonder on 06 Feb 2018
AusBiotech says plan to disadvantage life sciences innovation
6 February 2018 - Response to Innovation and Science Australia 2030 plan. ...
Posted by Michael Wonder on 31 Jan 2018
Industry needs clarity to invest in Australia
31 January 2018 - Medicines Australia welcomes the release of the 2030 plan by Innovation and Science Australia but seeks ...
Posted by Michael Wonder on 09 Jan 2018
Reflections on a landmark year for medical product innovation and public health advances and looking ahead to policy in 2018
9 January 2018 - As we look ahead to 2018, I’d like to take a moment to reflect on an ...
Posted by Michael Wonder on 14 Dec 2017
New steps to facilitate beneficial medical device innovation
14 December 2017 - In recent days, the FDA has committed to several new policies that will modernise the agency’s approach ...
Posted by Michael Wonder on 14 Dec 2017
Bumper crop of new drugs fails to lift big pharma R&D returns
14 December 2017 - It is shaping up to be a bumper year for drug approvals, with U.S. officials clearing twice ...
Posted by Michael Wonder on 08 Dec 2017
Remarks from FDA Commissioner as prepared for oral testimony before the U.S. Senate Committee on Health, Education, Labor & Pensions Hearing, “Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical Innovation
7 December 2017 - FDA Commissioner Gottlieb provides testimony before the U.S. Senate HELP Committee on the agency’s implementation of the ...