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

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.”

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

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).

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Issues facing foreign exporters: finding an initial distributor *

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.

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FDA issues much-anticipated draft guidance on de novo classification process *

USA - October 4 2011
The FDA’s draft guidance on the de novo classification process is finally available for comment purposes

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Amendment to Office for People with Developmental Disabilities regulations *

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.

Co-authors: Bethany J. Hills, Ellen V. Weissman.

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