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

Hodgson Russ LLP
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USA
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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
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USA
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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
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USA
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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FDA issues much-anticipated draft guidance on de novo classification process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
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USA
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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The FDA’s draft guidance on the de novo classification process is finally available for comment purposes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
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USA
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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
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USA
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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
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USA
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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
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USA
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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

FDA's proposed rules to improve food safety followed by raw milk raids

Hodgson Russ LLP
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USA
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May 18 2011

On May 5, 2011, just days before the FDA's pre-dawn raid on an Amish milk farmer in Pennsylvania (also see this article on related pending legislation), the FDA announced two interim final rules to implement portions of the Food Safety Modernization Act (FSMA

U.S. government accountability office update on FDA medical device oversight

Hodgson Russ LLP
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USA
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April 21 2011

On April 13, 2011, the United States Government Accountability Office (GAO) testified before the Senate Special Committee on Aging regarding FDA's regulation of high-risk medical devices

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