Engaging patients in medicines regulation: a tale of two agencies

2 December 2019 - The EMA and the US FDA have committed to engaging patients in their regulatory processes to promote ...

Read more →

Teva, drug makers in talks with U.S. to end generics probes

26 November 2019 - Deferred prosecution agreements among resolutions discussed. ...

Read more →

Acalabrutinib receives TGA approval for CLL and SLL cancers

25 November 2019 - The Therapeutic Goods Administration has approved the use of acalabrutinib (Calquence) for the treatment of patients ...

Read more →

FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukaemia

21 November 2019 - Today, as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, ...

Read more →

Regulators’ advice can make a difference for faster patient access to highly innovative therapies

12 November 2019 - Early dialogue and frequent interactions between medicine developers, regulators, health technology assessment bodies and patients can play ...

Read more →

FDA’s Project Orbis may expand to Singapore and Switzerland

12 November 2019 - The US FDA may expand a pilot project that allows for simultaneous drug approval decisions from ...

Read more →

ICER finalises method adaptations for assessing potential cures and other high-impact single or short-term therapies

12 November 2019 - Collaborative project with NICE and CADTH leads to important adaptations for ICER’s methods including creation of optimistic ...

Read more →

Patient perspective is vital to FDA's work

7 November 2019 - As an oncologist, I was eager to come work at the U.S. FDA, where I knew ...

Read more →

NICE International returns to deal with growing overseas enquiries

5 November 2019 - Division will offer an advisory service to international organisations, ministries and government agencies. ...

Read more →

Dialogue with Chinese authorities on medicine regulation

25 October 2019 - The Deputy Commissioner of the Chinese National Medical Product Administration, Dr Chen Shifei, visited EMA on ...

Read more →

Statement on FDA efforts to encourage patient engagement in medical device clinical investigations

23 September 2019 - At the U.S. FDA we are committed to keeping patients, their families and caregivers at the center ...

Read more →

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.  ...

Read more →

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. ...

Read more →

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 ...

Read more →

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 ...

Read more →