Blog
RSS FeedPosted by Michael Wonder on 17 Sep 2019
FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma
17 September 2019 - The U.S. FDA is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence. ...
Posted by Michael Wonder on 13 Aug 2019
DNA data shared in ways patients may find surprising
12 August 2019 - Hospitals engaged in private deals with drugmakers don’t always disclose the ways the data will be used. ...
Posted by Michael Wonder on 02 Aug 2019
FDA & European Medicines Agency collaborate on drug quality and manufacturing data to improve patient access to medically necessary medications
31 July 2019 - The FDA and the EMA are publishing the discussion and main conclusions from a workshop held ...
Posted by Michael Wonder on 21 Jul 2019
Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices
21 July 2019 - The objective was to develop and pilot a tool to measure and improve pharmaceutical companies’ clinical trial ...
Posted by Michael Wonder on 11 Jul 2019
Ensuring patient safety and drug manufacturing quality through partnership with European Union regulators
11 July 2019 - The Mutual Recognition Agreement with the European Union allows FDA to more effectively deploy our inspectional resources ...
Posted by Michael Wonder on 08 Jul 2019
Guido Rasi elected chair of International Coalition of Medicines Regulatory Authorities
8 July 2019 - The International Coalition of Medicines Regulatory Authorities has elected EMA’s Executive Director Guido Rasi as its ...
Posted by Michael Wonder on 01 Jul 2019
International work-sharing Initiative - niraparib (Zejula)
1 July 2019 - The TGA has approved a new drug for the treatment of some ovarian, fallopian tube, or ...
Posted by Michael Wonder on 24 Jun 2019
Incorporating patient preferences in non-inferiority trials
24 June 2019 - Non-inferiority trials imply a trade-off between a loss in efficacy of a standard treatment in exchange for ...
Posted by Michael Wonder on 11 Jun 2019
Two additional countries to benefit from EU-US mutual recognition agreement for inspections
11 June 2019 - On 10 June 2019, Luxembourg and the Netherlands were included into the mutual recognition agreement between ...
Posted by Michael Wonder on 06 Jun 2019
Strengthening engagement between EMA and general practitioners
6 June 2019 - EMA and the two major organisations representing general practitioners (GPs) and family physicians in Europe – ...
Posted by Michael Wonder on 02 Jun 2019
Campaign wants patients to have more influence on PBS
3 June 2019 - Australian patients should be given greater say in the medicines that receive government reimbursement as consumers ...
Posted by Michael Wonder on 24 May 2019
EMA facilitates early engagement with medicine developers to combat antimicrobial resistance
24 May 2019 - As of today, EMA is opening up the early dialogue available through its Innovation Task Force ...
Posted by Michael Wonder on 20 May 2019
Health Technology Assessment Consumer Consultative Committee March 2019 meeting communiqué
20 May 2019 - A communiqué from the March 2019 meeting of the HTA Consumer Consultative Committee has been published. ...
Posted by Michael Wonder on 09 Apr 2019
Health Canada approves new drug to treat metastatic breast cancer through international and domestic joint reviews
9 April 2019 - Canadians want improved access to the most recent and innovative treatment options for themselves and their ...
Posted by Michael Wonder on 09 Apr 2019
International work-sharing initiative - abemaciclib (Verzenio)
9 April 2019 - Abemaciclib (Verzenio) is the second medicine to be registered on the Australian Register of Therapeutic Goods ...