The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017
HHS Taking Comments on New Process to Enroll in Certain Health Programs
The Children’s Health Insurance Program Reauthorization Act (CHIPRA) authorized HHS to conduct a study of ELE to (1) examine state implementation of ELE and (2) evaluate subsequent changes in coverage or administrative costs. HHS expects to also use the evaluation to explore other mechanisms states are using to simplify enrollment, and how those strategies compare to ELE.
The Office of the Assistant Secretary for Planning and Evaluation (ASPE) will conduct the evaluation. ASPE will rely primarily on the following data collections: (1) administrative cost data from ELE and non-ELE states, (2) enrollment data from ELE and non-ELE states, (3) case studies in ELE and non-ELE states, including key informant interviews and focus groups, (4) a 50-state, plus DC, survey, and (5) quarterly monitoring calls with 30 states. HHS is seeking comments on the burden or other aspects of this information collection, and comments are due by May 30, 2012.
On 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders...03 January 2017
The Scottish government has announced plans to implement the 28 recommendations proposed in an independent review of access to new end-of-life, orphan and ultra-orphan medicines by patients ...23 December 2016