Blog
RSS FeedPosted by Michael Wonder on 03 Feb 2021
New toolbox available for EMA's PRIME designees
2 February 2021 - The European Medicines Agency has released a draft guidance to assist drug developers using its Priority ...
Posted by Michael Wonder on 25 Jan 2021
EMA publishes agenda for 25-29 January CHMP meeting
25 January 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 17 Dec 2020
FDA updates list of off-patent, off-exclusivity drugs without an approved generic
17 December 2020 - Today, the U.S. FDA published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved ...
Posted by Michael Wonder on 07 Dec 2020
EMA publishes agenda for 7-10 December CHMP meeting
7 December 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 12 Nov 2020
EMA publishes agenda for 9-12 November CHMP meeting
12 November 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 12 Oct 2020
EMA publishes agenda for 12-15 October CHMP meeting
12 October 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 06 Oct 2020
FDA discloses vaccine guidelines blocked by White House
7 October 2020 - The FDA has laid out its safety standards for developers of COVID-19 vaccines after the White House ...
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 14 Sep 2020
EMA publishes agenda for 14-17 September CHMP meeting
14 September 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 24 Aug 2020
FDA may fine clinical trial sponsors that don’t report data
24 August 2020 - The US FDA has said it will penalise sponsors of clinical trials that do not report ...
Posted by Michael Wonder on 18 Aug 2020
EMA publishes agenda for 17-20 August CHMP meeting
18 August 2020 - The EMA has published a draft agenda for this week's CHMP meeting (written procedure). ...
Posted by Michael Wonder on 18 Aug 2020
FDA finalises penalties for clinical trial sponsors that don’t share data, but critics say they fall short
18 August 2020 - After a year of deliberation, the FDA released final guidelines for penalising clinical trial sponsors that ...
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 21 Jul 2020
TGA publishes AusPAR for Vemlidy
21 July 2020 - AusPAR published within days of its provisional registration; why do other take years? ...