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.
In cooperation with Association of Corporate Counsel
  Request new password

Search results

Order by most recent / most popular / relevance

Results: 1-10 of 18

New York Nonprofit Revitalization Act of 2013 to have significant impact on state’s nonprofit corporations

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • February 24 2014

When New York State Governor Andrew Cuomo signed the Nonprofit Revitalization Act of 2013 into law on December 18, 2013, New York nonprofit

Industry reacts to FDA proposed revisions to acceptance of data from clinical studies for medical devices

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • July 18 2013

On February 25, 2013, the Food And Drug Administration (FDA) issued proposed rules to amend its regulations on acceptance of data from clinical

IOM report on food and medical product safety from foreign sources highlights large-scale shortcomings

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • April 24 2012

The Institute of Medicine (IOM) Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries recently issued a report entitled “Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad.”

FDA and FTC issue warnings for illegal homeopathic weight-loss remedies

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • December 20 2011

At the end of November, the Food and Drug Administration (FDA) issued warning letters to seven companies marketing diet products containing human chorionic gonadotropin (hCG

Issues facing foreign exporters: finding an initial distributor

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • October 24 2011

Companies that manufacture medical devices abroad (considered “foreign exporters” by the FDA) face a number of regulatory hurdles if they want to market their products in the U.S

FDA issues much-anticipated draft guidance on de novo classification process

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • October 4 2011

The FDA’s draft guidance on the de novo classification process is finally available for comment purposes

Amendment to Office for People with Developmental Disabilities regulations

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • September 6 2011

The Office for People with Developmental Disabilities (OPWDD) recently published proposed rules that could potentially affect two parts of Title 14 (regulations concerning the Department of Mental Hygiene) of the New York Codes, Rules, and Regulations (NYCRR)if they are ultimately adopted

Medical device user fees: recent developments

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • August 9 2011

The July 15 meeting minutes between the FDA and industry indicate that discussions continue to focus on “mitigating uncertainties” that exist in the medical device authorization process

Medical device user fees: FDA and industry continue to debate

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • July 21 2011

The FDA Amendments Act (FDAAA) requires that the FDA hold public meetings and conduct discussions with both the regulated industry and stakeholder groups in order to develop recommendations for the next Medical Device User Fee and Modernization Act (MDUFMA) program, which will span fiscal years 2013-17

Waiver required for certain entities providing social work or psychotherapy services

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • May 27 2011

In June 2010, the New York State Legislature passed a law addressing the practice of clinical social work and other scope-protected tasks, including the provision of mental health counseling and psychotherapy, in currently unauthorized corporate settings