We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 1,229

German perspective on new EU clinical trials regulation
  • McDermott Will & Emery
  • Germany
  • October 29 2014

On June 16 2014 EU Regulation 5362014 on Clinical Trials on Medicinal Products for Human Use entered into force. Once it becomes applicable, the


Upcoming health and welfare plan requirements checklist for employers
  • McDermott Will & Emery
  • USA
  • December 17 2014

As 2014 draws to a close, employers should turn their attention to several upcoming compliance obligations for the health and welfare benefit plans


FDA issues Revised Draft Guidance on disclosures of risk information in consumer-friendly print advertisements and promotional labeling
  • McDermott Will & Emery
  • USA
  • March 19 2015

The U.S. Food and Drug Administration (FDA) recently released its Revised Draft Guidance entitled “Brief Summary and Adequate Directions for Use:


Creeping normality: IRS releases final regulations under Section 501(R)
  • McDermott Will & Emery
  • USA
  • January 15 2015

On December 31, 2014, the U.S. Department of the Treasury And the Internal Revenue Service (collectively, IRS) released 64 pages of regulations


IRS publishes final forms and instructions on information reporting under the Affordable Care Act
  • McDermott Will & Emery
  • USA
  • February 26 2015

The Internal Revenue Service (IRS) published final forms and instructions addressing information reporting requirements applicable to employers and


The Newborn Screening Saves Lives Reauthorization Act: implications for human subjects research
  • McDermott Will & Emery
  • USA
  • April 8 2015

On March 16, 2015, the Newborn Screening Saves Lives Reauthorization Act of 2014 went into effect. The Act reauthorizes funding to improve and expand


Challenges facing “narrow” provider networks on the ACA health care insurance exchanges
  • McDermott Will & Emery
  • USA
  • April 20 2015

Health care insurers are trimming the number of contracted providers for their health care plans offered through the health benefit exchanges and the


Recent district of Massachusetts opinion explores Post-PPACA Public Disclosure Bar (and reminds relators that pleading a “scheme” is not enough under rule 9(b))
  • McDermott Will & Emery
  • USA
  • April 7 2015

In an opinion last week in U.S. ex rel. Hagerty v. Cybertronics, Inc., No. 1310214FDS, 2015 WL 1442497 (D. Mass. Mar. 31, 2015), the U.S. District


Skilled Nursing facilities: steps for reducing FCA liability
  • McDermott Will & Emery
  • USA
  • January 8 2015

Several government agencies have voiced concerns related to the level of therapy services necessary to care for residents of Skilled Nursing


FDA issues draft guidance on general wellness devices and on medical device accessories
  • McDermott Will & Emery
  • USA
  • February 4 2015

On January 16, 2015, the U.S. Food and Drug Administration (FDA) posted a draft guidance document outlining the FDA's proposed approach to the