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Bianca Nunes is an associate in the firm’s Washington, DC office, where she is a member of the Food and Drug practice group. She advises food, pharmaceutical, and biotechnology companies on a variety of regulatory and compliance issues.
January 5, 2017, Covington Alert
Yesterday, FDA issued a long-anticipated draft guidance intended to help industry comply with the agency’s May 2016 final rules modernizing nutrition labeling. Presented in a question-and-answer format, the draft guidance (Q&A Draft Guidance) provides information related to the compliance date, labeling of added sugars, rounding of the declaration of ...
November 2, 2016, Covington Alert
Last week, FDA released a draft guidance1 clarifying requirements for the “disclosure statement” provisions of its four major Food Safety Modernization Act (FSMA) rules. Entities subject to these provisions must disclose, in documents accompanying the food, that certain hazards have not been controlled. The draft guidance provides insight into the circumstances ...
August 25, 2016
Earlier this week, FDA released five chapters of a multi-chapter draft guidance on hazard analysis and risk-based preventive controls for human food. The long-awaited draft guidance is intended to help industry comply with certain requirements of the agency’s final rule for preventive controls for human food (PC rule) under the Food Safety Modernization Act ...
June 22, 2016, Webinar
November 25, 2015, Covington Alert
November 17, 2015, Covington Alert
September 17, 2015, Covington Alert
August 11, 2015, Inside Medical Devices
Cybersecurity vulnerability is becoming an increasing concern as medical devices are becoming more connected to the Internet, hospital networks, and other medical devices. As we previously reported, FDA has increasingly focused on promoting cybersecurity, recognizing that compromised medical devices can pose a risk to patient health and safety and to the ...
7/27/2015, Covington Alert
April 29, 2015, Covington E-Alert
March 11, 2015, Law360
February 23, 2015, Covington E-Alert
December 1, 2014, Covington E-Alert