Dominique Windberg

Dominique Windberg

Mintz Levin

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FDA and the Center for Food Safety Reach Settlement Regarding FDA’s GRAS Rule

On October 20, 2014, FDA reached a settlement with the Center for Food Safety (“CFS”) in litigation pending in the U.S. District Court for the District of Columbia. This litigation is related to FDA’s rule for food additives...more

10/31/2014 - FDA Food Manufacturers Food Safety

FDA Announces More Changes to FSMA Implementation Rules

On September 19, 2014, FDA announced potential changes to four rules that the agency proposed in 2013 to implement the Food Safety and Modernization Act (“FSMA”). FSMA was signed into law in January 2011 in response to many...more

10/7/2014 - FDA Food Manufacturers Food Safety FSMA Public Comment Public Meetings

FDA Issues Draft Guidance Regarding Controlled Correspondence from Generics Manufacturers

On August 26, 2014, the FDA issued draft guidance to address “controlled correspondence,” which is the correspondence that generic drug manufacturers submit to the FDA to request information and to clarify issues related to...more

9/10/2014 - Drug Manufacturers FDA Generic Drugs Pharmaceutical Prescription Drugs

California Supreme Court Considers Component Parts Doctrine

Last week, the California Supreme Court granted review of Ramos v. Brenntag Specialties, Inc. to resolve a split in the Second Appellate District regarding the application of California’s component parts doctrine. The...more

7/21/2014 - Component Parts Doctrine Liability Manufacturers Proposed Legislation

California Supreme Court Upholds Employment Class Action Waivers, but Rejects Waivers of PAGA Claims

The California Supreme Court issued an important decision last week on the enforceability of employment class action waivers included in arbitration agreements. The result: private parties can contract for the waiver of the...more

6/30/2014 - Arbitration Class Action Class Action Arbitration Waivers CLS Transportation Employment Contract Federal Arbitration Act Iskanian Mandatory Arbitration Clauses PAGA SCOTUS Trucking Industry

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