Blog
RSS FeedPosted by Michael Wonder on 20 Apr 2020
Improved Consumer Medicine Information template
20 April 2020 - The Therapeutic Goods Regulations 1990 have been amended to support improved Consumer Medicine Information. ...
Posted by Michael Wonder on 16 Apr 2020
EMA shares advice on validated computer systems used in clinical trials
16 April 2020 - The EMA has published a notice about validating and qualifying all types of computerised systems used ...
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 08 Apr 2020
Submissions on whether the TGA should publish that a prescription medicine is under evaluation
8 April 2020 - Between 15 February and 29 March 2019, the TGA sought comments from interested parties on the ...
Posted by Michael Wonder on 23 Mar 2020
EMA publishes agenda for 23-26 March CHMP meeting
23 March 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
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 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 25 Feb 2020
EMA publishes agenda for 24-27 February CHMP meeting
25 February 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 20 Feb 2020
Serving public health paramount in a successful 2019 for FDA’s generic drug program
19 February 2020 - Safe, effective, high-quality generic drugs play a vital role in the U.S. health care system. ...
Posted by Michael Wonder on 19 Feb 2020
Medical device application processing times
19 February 2020 - Australia's regulatory framework for therapeutic goods is undergoing a number of changes in response to the Review ...
Posted 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 09 Jan 2020
Human medicines: highlights of 2019
9 January 2020 - EMA has published a review of its key recommendations in 2019 on the authorisation and safety ...
Posted by Michael Wonder on 09 Dec 2019
EMA publishes agenda for 9-12 December CHMP meeting
9 December 2019 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 12 Nov 2019
EMA publishes agenda for 11-14 November CHMP meeting
11 November 2019 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 21 Oct 2019
Annual performance statistics report: July 2018 to June 2019
21 October 2019 - At 30 June 2019 there were 88,788 therapeutic goods on the ARTG, including 31,987 new products added ...