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U.S. Department of Agriculture's Proposed National Bioengineered Food Disclosure Standard Raises More Questions Than It Answers

USA - May 9 2018 On May 3, 2018, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) published its long-awaited proposed rule implementing...

Deepti A. Kulkarni, Anna K. Sims, Diane C. McEnroe.


FDA's Flurry of Food and Cosmetic Activities Continues Unabated

USA - January 9 2017 As the Obama administration draws to a close, the Food and Drug Administration's (FDA) Center for Food Safety and Applied...

Deepti A. Kulkarni, Sarah M. Goldstein, Diane C. McEnroe.


FDA's Final Medical Foods Guidance Maintains Restrictions on Category

USA - May 16 2016 On May 12, 2016, the Food and Drug Administration (FDA) finalized its August 2013 Draft Guidance, "Frequently Asked Questions About Medical Foods...

Sarah M. Goldstein, Scott Bass, Diane C. McEnroe.


New FDA Draft Guidance on Biosimilar Labeling Largely Follows Generic Drug Approach

USA - April 7 2016 On March 31, the U.S. Food and Drug Administration (FDA) published its long-awaited draft guidance, "Labeling for Biosimilar Products." While the...

Coleen Klasmeier, Peter S. Choi.


FDA Draft Guidance on BPCIA Transitional Provisions Would Rescind Innovator Exclusivities

USA - March 24 2016 The U.S. Food and Drug Administration (FDA) recently released draft guidance (Draft Guidance), entitled "Implementation of the 'Deemed to be a...

Sean C.Griffin, Peter S. Choi.