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
Final Rule to Implement Physician Payment Sunshine Act Released
The final rule announces that applicable manufacturers will be required to begin tracking reportable payments on August 1, 2013, and must submit their first disclosure reports to CMS by March 31, 2014.
The final rule also addresses a number of important outstanding issues with respect to implementation of the statute’s payment reporting requirements. In particular, the rule addresses:
- the definition of what manufacturers are covered under the law;
- how manufacturers should report payments related to research;
- whether and how manufacturers should report payments provided indirectly to a covered recipient through a third party;
- the scope of the statute’s exclusion of certain payments and transfers of value from the reporting obligation;
- submission, review, dispute, and correction of manufacturers’ disclosure reports;
- the format and content of the public website on which the reports will be posted; and
- the scope of the federal statute’s preemption of similar state laws.
We are developing a client alert with additional analysis of the key provisions of the final rule, which will be available on our website, http://www.hoganlovells.com, in the coming week.
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