Blog
RSS FeedPosted by Michael Wonder on 15 Feb 2019
FDA advances new efforts to promote development of safe and effective regenerative medicine products
15 February 2019 - Today, the FDA finalised two guidance documents regarding regenerative medicine therapies. ...
Posted by Michael Wonder on 08 Feb 2019
J&J becomes first drug maker to add prices to television ads
8 February 2019 - Johnson & Johnson said on Thursday it will start adding the price of its medicines to ...
Posted by Michael Wonder on 17 Jan 2019
FDA is urged to mandate disclosure of clinical trial summaries as pilot program stalls
16 January 2019 - One year after the FDA launched a voluntary pilot program to release clinical study reports, which ...
Posted by Michael Wonder on 14 Jan 2019
Revised guideline aims to strengthen global approach to development of new antibacterial medicines
14 January 2019 - EMA has published a PDF revision of its guideline on the evaluation of human medicines ...
Posted by Michael Wonder on 19 Dec 2018
FDA advances new scientific framework to promote greater predictability, efficiency in oncology drug development
19 December 2018 - Today, the U.S. FDA issued guidance, Clinical Trial Endpoints for the Approval of Cancer Drugs and ...
Posted by Michael Wonder on 15 Dec 2018
Highlights from the CHMP 10-13 December 2018 meeting
14 December 2018 - EMA’s CHMP recommended seven medicines for approval at its December 2018 meeting. ...
Posted by Michael Wonder on 12 Nov 2018
Drug prices on ads: as ‘relevant’ as percent daily value on food labels
9 November 2018 - President Trump announced late last month that his administration will push back on high drug costs ...
Posted by Michael Wonder on 01 Oct 2018
Congratulations. Your study went nowhere.
23 September 2018 - Researchers should embrace negative results instead of accentuating the positive, which is one of several biases that ...
Posted by Michael Wonder on 27 Sep 2018
TGA annual performance statistics report: July 2017 to June 2018
27 September 2018 - The statistics contained within this report cover the period 1 July 2017 to 30 June 2018, ...
Posted by Michael Wonder on 25 Sep 2018
To include or not include drug prices in DTC advertisements
24 September 2018 - For quite some time, consumer groups, patient advocates, and even several medical professional societies have called ...
Posted by Michael Wonder on 23 Sep 2018
FDA proposes stiff fines for failing to report clinical trials
20 September 2018 - Pharmaceutical companies could face penalties of up to US$10,000 per day. ...
Posted by Michael Wonder on 15 Sep 2018
Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource
12 September 2018 - Following the 2012 EC guideline, sponsors must ensure that all trials registered on EUCTR since 2004 disclose ...
Posted by Michael Wonder on 27 Aug 2018
FDA mandated listing of drug prices in ads would flunk legal and constitutional tests
27 August 2018 - We've read with amusement the recent, overblown claims of some constitutional-law commentators and even U.S. Supreme Court ...
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 25 Jul 2018
FDA publishes list of surrogate outcomes used in drug approvals
25 July 2018 - The US FDA on Wednesday published a list of surrogate outcomes to help inform drug developer ...