Blog
RSS FeedPosted by Michael Wonder on 07 Oct 2020
FDA issues guidance on Emergency Use Authorisation for COVID-19 vaccines
6 October 2020 - Today, the U.S. FDA issued guidance with recommendations for vaccine sponsors regarding the scientific data and ...
Posted by Michael Wonder on 02 Oct 2020
Biotech industry pushes Trump Administration to release new vaccine guidelines
2 October 2020 - The BIO trade group, whose members include most of the vaccine makers, asked the health secretary to ...
Posted by Michael Wonder on 17 Sep 2020
EMA close to finalising guidance for advanced therapies
16 September 2020 - The European Medicines Agency is on the verge of releasing revised guidance for advanced therapy medicinal ...
Posted by Michael Wonder on 31 Aug 2020
FDA releases draft guidance on PROs for device manufacturers
31 August 2020 - Device manufacturers have new draft guidance from the US FDA for the selection of patient-reported outcome ...
Posted by Michael Wonder on 31 Aug 2020
Consultation on the Medical Services Advisory Committee revised draft guidelines
31 August 2020 - The Department of Health is interested in obtaining views and feedback from the general public and ...
Posted by Michael Wonder on 27 Aug 2020
FDA works to evaluate cancer therapies in patients with brain metastases
27 August 2020 - Today, the U.S. FDA issued a draft guidance document, “Evaluating Cancer Drugs in Patients with Central Nervous ...
Posted by Michael Wonder on 19 Aug 2020
Keeping pace with pharmaceutical innovation: the importance of the NICE methods review
19 August 2020 - The NICE plays a vitally important role in ensuring patients get timely access to new medicines ...
Posted by Michael Wonder on 18 Aug 2020
FDA initiatives to accelerate the development of COVID-19 therapeutics
18 August 2020 - More than 750,000 deaths have occurred worldwide as a result of the novel coronavirus as of ...
Posted by Michael Wonder on 17 Aug 2020
Acute myeloid leukaemia: developing drugs and biological products for treatment
17 August 2020 - The purpose of this guidance is to assist sponsors in the clinical development of drugs and biological ...
Posted by Michael Wonder on 17 Aug 2020
MSAC Guidelines review
17 August 2020 - The Department of Health has commenced a review of the MSAC technical guidelines to ensure assessment ...
Posted by Michael Wonder on 06 Aug 2020
Principles for deliberative processes in health technology assessment
4 August 2020 - Deliberative processes are a well-established part of health technology assessment programs in a number of high- and ...
Posted 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 ...