RESOURCES

TTB Finalizes Portions of Modernization of Advertising and Labeling Regulations for Wine, Distilled Spirits, and Malt Beverages Rule
April 7, 2020 | 1:52 PM

By Dan Logan and Dan Dwyer On April 2, 2020, the Alcohol and Tobacco Tax and Trade Bureau (TTB) issued a final rule, Modernization of…

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LIVE WEBINAR: Hemp & CBD: FDA Update and the Impact of COVID-19
April 6, 2020 | 2:46 PM

Join Kleinfeld, Kaplan & Becker, LLP and Vicente Sederberg on Tuesday, April 7 at 2:15 p.m. ET for a live webinar on Hemp and CBD…

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Changes Made to the Federal Food, Drug, and Cosmetic Act by the CARES Act
April 3, 2020 | 5:47 PM

By: Daniel Logan and Justine Johnson The Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. L. No. 116–136) makes numerous changes to…

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New Opportunities for OTC Monograph Drugs under the CARES Act
April 2, 2020 | 4:11 PM

By: Daniel Dwyer and Daniel Logan On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act, or “CARES”…

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Shortage of PPE and other Devices During COVID-19 Pandemic – Is 3D Printing the Answer?
March 31, 2020 | 1:25 PM

By: Suzan Onel FDA issued a Press Release on March 28, 2020, reiterating what we all have seen in the news, there is a severe…

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FDA Issues Final Rule on Graphic Warnings for Cigarette Packages and Advertisements
March 30, 2020 | 9:51 AM

By: Stacy Ehrlich and Justine E. Johnson On March 18, 2020, the Food and Drug Administration (FDA) published a final rule (21 C.F.R. Part 1141)…

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It’s Not Always Easy Being Green – Lawsuit Related to “Recyclable” Claims Highlights Risks Related to Environmental Benefit Claims
March 27, 2020 | 9:13 AM

By: Jacqueline Chan and Vanessa Fulton Consumers are increasingly demanding environmentally-friendly products and packaging.  Driven by this increased demand and desire to create positive environmental…

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FDA Waives Certain Adverse Event Reporting Deadlines Across Product Industries During Pandemics
March 25, 2020 | 5:41 PM

By Suzan Onel and Vanessa Fulton On March 19, 2020, FDA issued a guidance document communicating its policy regarding postmarket adverse event reporting during a…

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FDA AMENDS THE DEFINITION OF “BIOLOGICAL PRODUCT” AND PREPARES FOR THE CONCLUSION OF A DECADE-LONG TRANSITION PERIOD
March 18, 2020 | 1:16 PM

By Jennifer A. Davidson and Justine E. Johnson On February 21, 2020, FDA published a final rule that, effective March 23, 2020, amends the regulatory…

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Kleinfeld, Kaplan & Becker is Fully Operational During the COVID-19 Pandemic
March 16, 2020 | 3:40 PM

During this current COVID-19 pandemic, Kleinfeld, Kaplan & Becker is fully operational, with attorneys and staff mostly working remotely.  Our telework system allows us to…

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