Blog
RSS FeedPosted by Michael Wonder on 08 Aug 2018
Patient reported outcome measures in the FDA pilot compendium: meeting today’s standards for patient engagement in development?
7 August 2018 - In 2016, the FDA released a pilot clinical outcome assessment compendium intended to foster patient-focused drug development. ...
Posted by Michael Wonder on 06 Aug 2018
FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder
6 August 2018 - The U.S. FDA today issued new scientific recommendations aimed at encouraging more widespread innovation and development of ...
Posted by Michael Wonder on 04 Aug 2018
Statement from FDA Commissioner Scott Gottlieb on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes
3 August 2018 - As a public health agency, there is no greater impact we can have to improve the ...
Posted by Michael Wonder on 20 Jul 2018
Statement from FDA Commissioner on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse
20 July 2018 - One of the ways that the U.S. FDA is working to address the opioid epidemic is ...
Posted by Michael Wonder on 20 Jul 2018
FDA provides scientific and regulatory clarity for generic drug developers through the issuance of 43 new or revised product-specific guidance documents, including hard-to-copy complex generics and abuse-deterrent formulations of opioids
20 July 2018 - The U.S. FDA today announced a new batch of product-specific guidances to support industry in identifying ...
Posted by Michael Wonder on 13 Jul 2018
PhRMA statement on efforts to support real world evidence
12 July 2018 - PhRMA spokesperson Andrew Powaleny issued the following statement on comments made by U.S. FDA Commissioner Scott Gottlieb. ...
Posted by Michael Wonder on 11 Jul 2018
Statement from FDA Commissioner on agency’s efforts to advance development of gene therapies
11 July 2018 - Once just a theory, gene therapies are now a therapeutic reality for some patients. ...
Posted by Michael Wonder on 03 Jul 2018
Deloitte survey finds biopharma companies are accelerating adoption of real-world evidence
28 June 2018 - A recent survey shows that 90% of biopharma companies are making significant investments in real-world evidence ...
Posted by Michael Wonder on 28 Jun 2018
Bias, operational bias, and generalisability in Phase II/III trials
27 June 2018 - Adaptive clinical trial designs improve the efficiency of the drug development process by allowing treatment decisions to ...
Posted by Michael Wonder on 27 Jun 2018
Metastasis-free survival — a new end point in prostate cancer trials
27 June 2018 - Earlier this year, the FDA approved apalutamide, an androgen receptor inhibitor, for treatment of patients with non-metastatic ...
Posted by Michael Wonder on 25 Jun 2018
Statement by FDA Commissioner on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components
25 June 2018 - Over the past decade, we’ve seen a growing interest in the development of therapies derived from marijuana ...
Posted by Michael Wonder on 21 Jun 2018
FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies
21 June 2018 - Today, the agency withdrew the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September ...
Posted by Michael Wonder on 20 Jun 2018
Budget matters: infrastructure to support robust generic drug competition
18 June 2018 - The FDA launched its Drug Competition Action Plan more than a year ago, with the aim of ...
Posted by Michael Wonder on 19 Jun 2018
Modernising the orphan designation process
19 June 2018 - The EMA has launched a new secure online portal for orphan designationExternal link icon applications. ...
Posted by Michael Wonder on 19 Jun 2018
Sandoz Canada becomes the first Canadian pharmaceutical company to enter the medical cannabis field
19 June 2018 - Sandoz Canada and Tilray finalise alliance to provide Canadians with greater access to high-quality, non-combustible medical cannabis ...