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 OIG Releases Proposed Rule Regarding Exclusion from Federal Health Care Programs
The proposed rule codifies the OIG’s authority to impose permissive exclusion for:
- Convictions relating to obstruction of an investigation or audit;
- Failure to provide payment information, including by individuals who “order, refer for furnishing, or certify the need for” items or services paid for by Medicare or State health care programs; and
- Making false statements or misrepresenting materials facts in applications to participate as a provider or supplier under a Federal health care program.
Other proposed changes include proposing early reinstatement rules for individuals excluded as a result of losing their licenses, the mandatory exclusion waiver provision, amendments of mitigating and aggravating factors, and other administrative process changes.
Hogan Lovells is currently analyzing the proposed rule and is happy to provide additional information upon request.
Comments to the proposed rules must be received to OIG by 5 PM EST on July 8, 2014.
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