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
IRS Addresses Health Plan Fees Imposed to Fund PCORI
Under the proposed rule, insurers are given four options in calculating the number of covered lives under the proposed rule: the actual count method, the snapshot method, the member months method, or the state form method. The proposed rule also sets forth certain exemptions from this fee. For example, ex-patriot, stop-loss, reinsurance plan, and most wellness and disease management programs, as well as plans that provide mainly excepted benefits (e.g., accident, disability, and worker’s compensation) would be exempted from the fee. In addition, the IRS clarifies that employers offering flexible spending and health savings accounts along with major medical coverage will not be double charged for the fee.
The IRS will hold a public hearing to discuss the proposed rules on August 8, 2012. Stakeholders who wish to submit comments are asked to do so by July 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