On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 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.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017