The FDA’s Digital Health Center Of Excellence: why it matters and what it means to you

29 October 2020 - Last month, the US FDA launched the Digital Health Center of Excellence, bolstering the shift toward digital ...

Read more →

European Union would apply lower threshold in assessing COVID-19 vaccine

25 October 2020 - The EU’s drug regulator is willing to approve a vaccine even if it were effective in less ...

Read more →

The FDA and the importance of trust

30 September 2020 - As SARS-CoV-2 emerged, the global scientific community first studied the virus at the bench, then took what ...

Read more →

Biopharma leaders unite to stand with science

8 September 2020 - Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the ...

Read more →

FDA head pledges 'we will not cut corners' on coronavirus vaccine

10 August 2020 - The head of the FDA pledged Monday that the U.S. "will not cut corners" in its ...

Read more →

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 ...

Read more →

Pharma execs say FDA will not lower standards for coronavirus vaccine

21 July 2020 - Drug company executives sought to reassure House Democrats that the federal government is not lowering its ...

Read more →

Bayer's chloroquine donation to U.S. raises concern about FDA standards in pandemic

16 April 2020 - On March 21, two days after President Donald Trump first touted chloroquine drugs as a “game ...

Read more →

NICE publishes updated principles

30 January 2020 - NICE has today, 30 January 2020, published a simple guide to the way we develop our guidance ...

Read more →

Two words to help Ned Sharpless revolutionise clinical trials: data standards

13 May 2019 - In the classic 1967 film “The Graduate,” young Benjamin Braddock was given one word of advice ...

Read more →

Italy proposes the WHO set international standards for drug pricing transparency

14 February 2019 - As more countries seek to control their health care spending, the Italian government is asking the ...

Read more →

Identifying the need for good practices in health technology assessment-summary of the ISPOR HTA Council Working Group Report on Good Practices in HTA

26 January 2019 - The systematic use of evidence to inform healthcare decisions, particularly health technology assessment, has gained increased recognition.  ...

Read more →

Physicians’ perspectives on FDA approval standards and off-label drug marketing

22 January 2019 - Recently, two fundamental aspects of the US FDA’s pharmaceutical market oversight have become controversial.  ...

Read more →

New NICE standards to improve digital health tech uptake

12 December 2018 - NICE has published new standards setting out the requirements needed to develop digital health technologies for ...

Read more →

Advancing toward the goal of global approval for generic drugs: FDA proposes critical first steps to harmonise the global scientific and technical standards for generic drugs

18 October 2018 - Too many Americans struggle with the high cost of drugs. In some cases, patients go without ...

Read more →