17 January 2020 - Failure to report the results of a clinical trial can distort the evidence base for clinical practice, ...
30 September 2019 - Today the U.S. FDA issued a draft guidance on Patient-Focused Drug Development: Methods to Identify What Is ...
20 September 2019 - This document provides guidance to sponsors and applicants on interacting with the FDA on complex innovative trial ...
29 August 2019 - A Food and Drug Administration proposal to substitute detailed reviews of new drugs written by specific ...
11 June 2019 - In 2010, the FDA issued draft recommendations on increasing the transparency of the FDA’s processes and ...
4 June 2019 - Remember in high school when a friend told you a secret and you guarded it assiduously, ...
8 May 2019 - Today, the U.S. FDA published the draft guidance, Submitting Documents Using Real-World Data and Real-World Evidence ...
15 February 2019 - Today, the FDA finalised two guidance documents regarding regenerative medicine therapies. ...
8 February 2019 - Johnson & Johnson said on Thursday it will start adding the price of its medicines to ...
16 January 2019 - One year after the FDA launched a voluntary pilot program to release clinical study reports, which ...
19 December 2018 - Today, the U.S. FDA issued guidance, Clinical Trial Endpoints for the Approval of Cancer Drugs and ...
9 November 2018 - President Trump announced late last month that his administration will push back on high drug costs ...
23 September 2018 - Researchers should embrace negative results instead of accentuating the positive, which is one of several biases that ...
24 September 2018 - For quite some time, consumer groups, patient advocates, and even several medical professional societies have called ...
20 September 2018 - Pharmaceutical companies could face penalties of up to US$10,000 per day. ...