Representing clients in matters of Florida and federal laws and regulations. Licensed to practice law in Florida, only.
The FTC sued Lens.com over hidden fees and warned 24 health care companies about pricing. Learn what these FTC pricing enforcement actions mean for your business.
Read MoreFDA-regulated products remain subject to regulatory risk across the supply chain. FDA’s September 23 action against Gold Star Distribution is a reminder that warehousing and distribution are part of the regulated product supply chain. Tips for managing 3PL, warehousing, distribution, supplier, and compliance risks for food, drug, medical devices, and cosmetics across state and federal requirements.
Read MoreFlorida Health Care Clinic license application submission on behalf of health care providers should be handled by experienced health care attorneys.
Read MoreThe U.S. Food and Drug Administration (FDA) on January 2, 2020, issued a policy prioritizing enforcement against flavored e-cigarette products that are manufactured and marketed in a manner that appeal to minors because the are flavored or marketed to taste or look like popular cereals, juices, or candies. Since implementation of the FDA’s premarket authorization
Read MoreFDA’s 510(k) Third-Party Review program benefits the public health by allowing low-to-moderate risk medical devices obtain FDA-equivalent review while enabling FDA to focus more resources on higher risk and more complex devices.
Read MoreU.S. Food and Drug Administration (FDA) issued a Warning Letter to U.S. food importer, B&I Overseas Trading Inc., for failing to implement supplier verification protocols, as required under the “Foreign Supplier Verification Program” (FSVP), to assure that fish imported by the company into the U.S. was produced in accordance with U.S. food safety regulations. In the FDA
Read MoreIn light of the recently finalized Deeming Rule, the FDA has been conducting periodic compliance check inspections to determine tobacco retail establishment’s compliance with the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) and found several violations of the federal tobacco laws and regulations while conducting inspections. As a result, the FDA has
Read MoreRetailers, manufactures and retailer/manufacturers of tobacco products should take note that compliance with the U.S. Food and Drug Administration (FDA) new tobacco rules is rapidly approaching. Certain provisions of the final rule become effective Monday, August 8, 2016. On May 10, 2016, the FDA issued its final rule expanding the FDA’s definition of “tobacco
Read MoreOn June 9, 2016, The U.S. Food and Drug Administration (FDA) announced that it took action against 4,402 websites illegally selling unapproved prescription drugs to U.S. consumers. With the assistance of U.S. Customs and Border Protection, the FDA conducted inspections at International Mail Facilities (IMFs) and served formal complaints on domain registrars “requesting the suspension
Read MoreOn May 12, 2016 the U.S. Food and Drug Administration (FDA) published a draft guidance titled “Use of Electronic Health Record Data in Clinical Investigation,” which is intended to guide clinical trial sponsors, investigators, contract research organizations (CRO), and institutional review boards (IRB) on the use of electronic health record (EHR) data in FDA-regulated clinical
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