Emerging use of early health technology assessment in medical product development: a scoping review of the literature

20 June 2017 - Early health technology assessment is increasingly being used to support health economic evidence development during early stages ...

Read more →

Fostering medical innovation: a plan for digital health devices

15 June 2017 - It is incumbent upon FDA to ensure that we have the right policies in place to promote ...

Read more →

Workshop: addressing unmet needs of children with pulmonary arterial hypertension

6 June 2017 - The EMA, the United States FDA and Health Canada are co-organising a workshop to discuss the ...

Read more →

How patients are changing clinical trials

17 May 2017 - In September, the FDA approved a controversial drug to treat Duchenne muscular dystrophy, a rare but deadly ...

Read more →

The failure of solanezumab — How the FDA saved taxpayers billions

3 May 2017 - The failure of solanezumab offers a window into the U.S. drug regulatory system, particularly in the context ...

Read more →

Evaluation of evidence of statistical support and corroboration of sub-group claims in randomised clinical trials

3 April 2017 - Many published randomised clinical trials make claims for subgroup differences. ...

Read more →

The nominee to run America’s drug regulator is a sound choice

1 April 2017 - Scott Gottlieb is close to the pharma industry but knows its tactics. ...

Read more →

FDA: helping small businesses get big results

30 March 2017 - It is well known that small business is vital to the success of the American economy. Less ...

Read more →

Trump’s nominee to lead the FDA got paid millions by the health care industry

29 March 2017 - Dr. Scott Gottlieb, President Donald Trump's nominee to head the FDA, is a widely respected physician ...

Read more →

An FDA program incentivising rare disease drugs will be investigated for abuses

23 March 2017 - In late 1982, Congress overwhelmingly passed the Orphan Drug Act, which was then signed into law ...

Read more →

GAO: drug makers want more clarity on antibiotic incentives

3 March 2017 - Despite some improvements, drug makers say the US FDA has not fully clarified its expectations for ...

Read more →

Trump vows to 'slash restraints' on drug development for FDA

1 March 2017 - President Donald Trump used his first address to a joint session of Congress on Tuesday to, ...

Read more →

Privatised pharmaceutical innovation vs access to essential medicines: a global framework for equitable sharing of benefits

7 February 2017 - The effect of the current privatized model of pharmaceutical innovation on the development and affordability of lifesaving ...

Read more →

U.S. House panel to take up bill to spur generic drug development

2 February 2017 - A U.S. House of Representatives subcommittee will take up bipartisan legislation next week to foster generic ...

Read more →

Drug development challenges for small biopharmaceutical companies

1 February 2017 - Small biopharmaceutical companies are becoming increasingly important as drivers of innovation in drug development. ...

Read more →