Blog
RSS FeedPosted by Michael Wonder on 01 Jul 2020
International regulators provide guiding principles for COVID-19 clinical trials
1 July 2020 - EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International ...
Posted by Michael Wonder on 30 Jun 2020
FDA takes action to help facilitate timely development of safe, effective COVID-19 vaccines
30 June 2020 - Today, the U.S. FDA took important action to help facilitate the timely development of safe and effective ...
Posted by Michael Wonder on 30 Apr 2020
Procedure Guidance for standardised redactions to PBAC Public Summary Documents
30 April 2020 - The PBAC has indicated its preference for greater transparency to be introduced in PSDs through a ...
Posted by Michael Wonder on 23 Apr 2020
NICE publishes two new COVID-19 guidelines
23 April 2020 - NICE has published 2 new rapid COVID-19 guidelines on the care of patients with suspected and confirmed ...
Posted by Michael Wonder on 22 Apr 2020
New U.S. treatment guidelines for COVID-19 don’t see much progress
21 April 2020 - A panel of experts said there was insufficient evidence about many drugs that have been considered as ...
Posted by Michael Wonder on 15 Apr 2020
Product specific guidances for chloroquine phosphate and hydroxychloroquine sulphate
13 April 2020 - The FDA plays a critical role in protecting the United States from threats including emerging infectious ...
Posted by Michael Wonder on 09 Apr 2020
NICE publishes new COVID-19 guidelines on cystic fibrosis, chronic obstructive pulmonary disease and dermatological conditions treated with drugs affecting the immune response
9 April 2020 - NICE has today published 3 new rapid guidelines on the care of patients with suspected and confirmed ...
Posted by Michael Wonder on 04 Apr 2020
NICE publishes new COVID-19 guidelines on severe asthma, pneumonia, rheumatological disorders and symptom management
4 April 2020 - They cover the management of patients with severe asthma, pneumonia, rheumatological autoimmune, inflammatory and metabolic bone disorders ...
Posted by Michael Wonder on 30 Mar 2020
New WHO guide to help countries expand access to essential medicines
30 March 2020 - WHO’s new user guide for countries, ‘Selection of medicines at country level’, is based ...
Posted by Michael Wonder on 30 Mar 2020
Updated Financial Estimates workbook and manual
30 March 2020 - An updated version of the Utilisation and Cost Model workbook and a user manual are now available ...
Posted by Michael Wonder on 24 Mar 2020
Global regulators map out data requirements for phase 1 COVID-19 vaccine trials
24 March 2020 - Global regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine ...
Posted by Michael Wonder on 21 Mar 2020
NICE publishes first rapid COVID-19 guidelines
21 March 2020 - New guidelines cover the management of patients in critical care, the management of patients who are having ...
Posted by Michael Wonder on 18 Mar 2020
Coronavirus (COVID-19) update: FDA issues guidance for conducting clinical trials
18 March 2020 - The U.S. Food and Drug Administration today issued a guidance for industry, investigators and institutional review ...
Posted by Michael Wonder on 15 Mar 2020
FDA finalises guidance for industry on applications for drugs with inadequate generic competition
13 March 2020 - Today, the U.S. FDA finalised guidance for industry, “Competitive Generic Therapies” (CGTs), which describes the process that ...
Posted by Michael Wonder on 09 Mar 2020
FDA proposes broad approach for conducting safety trials for type 2 diabetes medications
9 March 2020 - The U.S. FDA today issued a new draft guidance, “Type 2 Diabetes Mellitus: Evaluating the Safety ...