Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 09 Mar 2020
Reformatting Product Information: frequently asked questions
6 March 2020 - A new product information form was approved on 8 November 2017, with a commencement date of ...
Posted by Michael Wonder on 09 Feb 2020
Biosimilars and interchangeable biosimilars: licensure for fewer than all conditions of use for which the reference product has been licensed guidance for industry
5 February 2020 - This guidance provides recommendations to applicants seeking licensure under section 351(k) of the Public Health Service Act ...
Posted by Michael Wonder on 28 Jan 2020
FDA continues strong support of innovation in development of gene therapy products
28 January 2020 - This is a pivotal time in the field of gene therapy as the FDA continues its ...
Posted by Michael Wonder on 05 Jan 2020
Beyond “Intent‐to‐treat” and “Per protocol”: improving assessment of treatment effects in clinical trials through the specification of an estimand
27 December 2019 - There is a key problem in randomised clinical trials as outcomes can be distorted due to ...
Posted by Michael Wonder on 12 Dec 2019
FDA issues draft guidance to foster oncology product development for paediatric populations
12 December 2019 - Today, the U.S. FDA issued a draft guidance document, “FDARA Implementation Guidance for Pediatric Studies of ...