On 15 November 2016, the European Commission (“the Commission”) opened its second report on Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12...08 December 2016
340B Program: U.S. District Court for the District of Columbia Vacates HRSA's Final Rule on the 340B Orphan Drug Exclusion
On Friday, May 23, 2014, the U.S. District Court for the District of Columbia "vacated," or invalidated, the Health Resources and Services Administration's (HRSA) final rule on the treatment of orphan drugs under the 340B Drug Discount Program. HRSA, which administers the 340B program, released the final rule in July 2013.
On 26 September 2016, a new EU-US collaboration between the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) was announced. This new collaboration is ...06 October 2016
As reported here, earlier this month the U.S. Drug Enforcement Administration (DEA) issued a decision declining to transfer marijuana out of Schedule I. As marijuana remains a Schedule I...07 September 2016