Category Archives: Uncategorized

22 Jun

New FDA Guidance Targets Electronic Health Records in Clinical Trials

On May 12, 2016 the U.S. Food and Drug Administration (FDA) published a draft guidance titled “Use of Electronic Health Record Data in Clinical Investigation,” which is intended to guide clinical trial sponsors, investigators, contract research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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22 Jun

FDA issues Draft Guidance on 3D Printing of Medical Devices

On May 10, the U.S. Food and Drug Administration (FDA) issued draft guidance titled “Technical Considerations for Additive Manufactured Devices” providing its initial thoughts on regulatory requirements for additive manufactured (AM)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

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05 May

FDA Authority Over E-cigarettes Expanded

The Food and Drug Administration (FDA) today announced long-awaited final rules expanding the FDA’s authority over e-cigarettes and other tobacco products.  The rule broadens the definition of tobacco products to include e-cigarettes, hookahs, pipe tobacco, premium cigars, little cigars and other products. Acting under its authority as established through the Tobacco Control Act of 2009, the FDA has

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30 Apr

FDA Warning Letters demand “immediately cease distribution” of dietary supplements with BMPEA

On April 23, 2015 the U.S. Food and Drug Administration (FDA) issued warning letters to several dietary supplement companies distributing dietary supplements containing beta-methylphenethylamine (BMPEA), an ingredient widely used in weight loss,  energy, and exercise endurance supplements. Studies show that BMPEA can cause an accelerated and irregular heartbeat. These warning letters come over one year

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07 Apr

Pesticide Companies Selling Antimicrobial Pesticide with Unapproved Claims to Pay Civil Penalties to EPA

Integrated Environmental Technologies (IET), a South Carolina based pesticide registrant, and Seriously Clean, Ltd., of Nixa, Mo., a firm that served as an authorized distributor of IET’s product under a different brand name, have agreed to pay civil penalties of $87,344 and $91,829, respectively, to the Environmental Protection Agency (EPA) to settle alleged violations of

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16 Jan

Spa Owner Sentenced to Prison for Illegal Sylicone Injections

Elva Navarro, of Hidalgo,Texas,  has been sentenced to three years in federal prison to be immediately followed by one year of supervised release for violating the U.S. Food, Drug and Cosmetics Act by using an adulterated device. Court documents demonstrated that Navarro administered injections of liquid silicone into individuals who would frequent her facility – Bella

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21 Jan

FTC target deceptive advertisers of weight-loss products

On January 7, 2014, the Federal Trade Commission (FTC) announced a law enforcement initiative to stop deceptive advertising claims to relating to weight- loss products, from food additives and skin cream to dietary supplements. Recognizing that Americans spend billions of dollars every year on supplements, foods and devices in hopes of improving their health and

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08 Oct

Florida DOH unveils new approach to medical license renewals

Licensees of the Department of Health are required to renew their licenses biennially in order to maintain the right to practice in the health care industry.  The DOH required medical doctors to renew their licenses in two groups: Group 1 – current license will expire at midnight, Eastern Time, January 31, 2014 Group 2 – current license will expire

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