FDA Q&A

New FDA Automatic Destruction Rule

Under New Authority Re-Export Option May be Removed An ominous sounding new rule goes into effect tomorrow (October 15, 2015). The rule is titled, “Administrative…

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FDA Shutdown – Preparing for the Likely Government Shutdown

***UPDATE: Congress approved a short term budget deal that will fund the government through December 11th. There remains a liklihood that a FDA shutdown could…

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FDA SEC Reporting – Regulatory Reviews for SEC Forms

FDA SEC Reporting Regulatory Reviews in Form 8-K FDA SEC Reporting does not readily come to mind when considering foods, dietary supplements, drugs, cosmetics (so…

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FDA Label Review – Overview and Tips

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New FDA Expedited Access Pathway Program

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FDA, FSMA, and the USDA Budget Increases- Update from Latest Spending Bill

The latest reporting on the spending bill passed by the United States House of Representatives contains budget increases for the U.S. Food and Drug Administration…

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Gluten Free Label Rule Now In Effect

Last year the US Food and Drug Administration (FDA) annouced a new rule for gluten free labeling. The rule gave manufacturers until yesterday (August 5,…

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Press Release: Springer Taps Marc Sanchez for Food Law Textbook

  For Immediate Release: June 23, 2014 Marc C. Sanchez, Esq.             Senior Counsel, Contract In-House Counsel and Consulting, LLC Adjunct Professor of Law, Northeastern…

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Tips for Appeals and FDA Meetings: Reflections from Recent Visit to FDA HQ

An enforcement meeting with the US FDA, whether in person or over the phone, can become an intimidating task. There are number of variables to…

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Marijuana, THC, and the US FDA – What Does Increasing Legalization Mean for Food, Drugs, and Dietary Supplements?

Colorado made headlines this past week when its decriminalization of marijuana went into effect. Since that time an increasing number of calls and e-mails rushed…

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Trans Fat Banned Under New FDA Rule

The US Food and Drug Administration announced today it will take steps to curb the use of partially hydrogenated oils from processed foods. The Agency…

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FDA/USDA Shutdown Ending, Expect Lengthy Delays

The government shutdown that shuttered the doors of the USDA and FDA has ended. The Agencies are expected to return back to normal operations on…

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