Friday, July 8, 2016
The EMA acknowledges the outcome of the referendum of June 23, 2016. A majority voted against U.K.’s continued membership of the European Union (EU) and it is now up to the U.K. government to decide how to act upon the outcome of the referendum.
In support of the President’s Precision Medicine Initiative, the FDA has issued two draft guidances that, when finalized, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person’s genomic makeup.
Patient engagement has been a hot topic in clinical research in recent years, and it looks like regulators may finally be catching up. Or trying to.
FDA Commissioner Robert Califf, M.D., released a statement announcing the acting director of the FDA Oncology Center of Excellence. He said:
The Union Cabinet, chaired by the Prime Minister Shri Narendra Modi, has decided to withdraw the Drugs and Cosmetics (Amendment) Bill, 2013, which had been introduced in the Rajya Sabha in August of 2013. The Bill had been examined by the Standing Committee of Parliament which had made a number of recommendations for changing the provisions of the Bill.
The EMA and the FDA have set up a new ‘cluster’ on patient engagement. The cluster will provide a forum to share experiences and best practices on the way the two agencies involve patients in development, evaluation and post-authorization activities related to medicines.
A shocking case of insider trading has rocked the drug development world and beyond.
FDA Commissioner Robert M. Califf, M.D., has suggested that establishing a government-sponsored database of preclinical studies could improve transparency in drug development and the ability of researchers to reproduce study results.