Blog
RSS FeedPosted by Michael Wonder on 18 Sep 2018
Harvard Professor's attack on pharma's clinical trials is absurd
18 September 2018 - Dr. Marcia Angell, a senior lecturer at Harvard Medical School and the first woman to serve as ...
Posted by Michael Wonder on 17 Sep 2018
Antimicrobial resistance: FDA discusses reimbursement reforms
17 September 2018 - Reimbursement reforms for antimicrobial treatments could include “a mix of milestone payments and subscription fees for ...
Posted by Michael Wonder on 10 Sep 2018
Endocyte announces FDA acceptance of radiographic progression free survival as an alternative primary endpoint of the VISION trial in addition to overall survival
10 September 2018 - Demonstrating benefit in rPFS versus control, with no detriment to OS, sufficient for full approval. ...
Posted by Michael Wonder on 05 Sep 2018
The path to the first FDA approved cannabis-derived treatment and what comes next
5 September 2018 - Harvard neurologist Elizabeth Thiele is only half-kidding about the surprising direction her research has taken. ...
Posted by Michael Wonder on 31 Aug 2018
Choice of control group in randomised trials of cancer medicine: are we testing trivialities?
31 August 2018 - Several trials in cancer medicine over the past 5 years share two common features: first, they were ...
Posted by Michael Wonder on 29 Aug 2018
FDA pushes for development of non-opioid pain medications
29 August 2018 - The FDA is planning new steps to encourage the development of nonaddictive alternatives to opioid pain ...
Posted by Michael Wonder on 29 Aug 2018
FDA launches new pilot to advance innovative clinical trial designs as part of agency’s broader program to modernise drug development and promote innovation in drugs targeted to unmet needs
29 August 2018 - Today, the U.S. FDA announced a new pilot program (“Complex Innovative Designs Pilot Meeting Program”) in which ...
Posted by Michael Wonder on 25 Aug 2018
FDA says sponsors should limit placebo controlled trials in cancer
23 August 2018 - FDA released draft guidance on Thursday to debunk the notion that FDA requires the use of ...
Posted by Michael Wonder on 22 Aug 2018
Statement by FDA Commissioner on new steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics
22 August 2018 - As we all work to confront the staggering human and economic toll created by the opioid crisis, ...
Posted 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. ...