Blog
RSS FeedPosted by Michael Wonder on 20 Jan 2020
Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study
17 January 2020 - Failure to report the results of a clinical trial can distort the evidence base for clinical practice, ...
Posted by Michael Wonder on 30 Sep 2019
FDA issues draft guidance on patient-focused drug development: methods to identify what is important to patients
30 September 2019 - Today the U.S. FDA issued a draft guidance on Patient-Focused Drug Development: Methods to Identify What Is ...
Posted by Michael Wonder on 22 Sep 2019
Interacting with the FDA on complex innovative trial designs for drugs and biological products
20 September 2019 - This document provides guidance to sponsors and applicants on interacting with the FDA on complex innovative trial ...
Posted by Michael Wonder on 29 Aug 2019
Academics and consumer groups protest FDA plan to summarise review documents
29 August 2019 - A Food and Drug Administration proposal to substitute detailed reviews of new drugs written by specific ...
Posted by Michael Wonder on 11 Jun 2019
Should the FDA disclose new filings for drugs, biologics and biosimilars?
11 June 2019 - In 2010, the FDA issued draft recommendations on increasing the transparency of the FDA’s processes and ...
Posted by Michael Wonder on 04 Jun 2019
Hiding in plain sight: the FDA’s approach to disclosing new drug applications is a disservice to public health
4 June 2019 - Remember in high school when a friend told you a secret and you guarded it assiduously, ...
Posted by Michael Wonder on 09 May 2019
FDA issues draft guidance to industry on submitting real-world evidence in new drug and biologic applications
8 May 2019 - Today, the U.S. FDA published the draft guidance, Submitting Documents Using Real-World Data and Real-World Evidence ...
Posted 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 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 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 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. ...