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
CMS Hears Opposition to Preliminary Decisions on HCPCS Codes at Second of Three Public Meetings
The first of these meetings, held on May 8, 2013, addressed the preliminary decisions regard code requests for drugs, biologicals, and radiopharmaceuticals. In its preliminary decisions, the HCPCS Workgroup proposed granting the majority of coding requests.
The second meeting, held yesterday, addressed supplies and “other” products and services. Presenters supporting a dozen applications spoke at the meeting, opposing CMS’s preliminary decisions. In its preliminary decisions, CMS did not grant a single applicant’s code request. The limited interplay between speakers on behalf of applicants for a code and the HCPCS Workgroup suggests that many of the preliminary decisions issued may be finalized as proposed.
Similarly, CMS’s preliminary decisions regarding Durable Medical Equipment (DME) and Accessories, to be discussed at the third public meeting on June 4, 2013, granted very few of the applicants’ requests. Information about how to attend the final public meeting can be found on the CMS website.
Based on additional information and discussion at the public meetings, CMS may alter preliminary decisions. Final decisions will released be in late October or early November.
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