Representing clients in matters of Florida and federal laws and regulations. Licensed to practice law in Florida, only.
On 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Read MoreOn May 12, 2016 the U.S. Food and Drug Administration (FDA) published a draft guidance titled “Use of Electronic Health Record Data in Clinical Investigation,” which is intended to guide clinical trial sponsors, investigators, contract research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
Read MoreOn May 10, the U.S. Food and Drug Administration (FDA) issued draft guidance titled “Technical Considerations for Additive Manufactured Devices” providing its initial thoughts on regulatory requirements for additive manufactured (AM) devices (aka 3D printed medical devices), the category of manufacturing that includes 3-dimensional (3D) printing. The FDA described this as a “leapfrog” guidance through
Read MoreThe Food and Drug Administration (FDA) recently issued a final guidance declaring use of the term “evaporated cane juice” (ECJ) on food labeling to be misleading. “Evaporated cane juice” is a term commonly used on food labels to identify the presence of sweeteners derived from the fluid extract of sugar cane. However, FDA’s most recent
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