FDA Stops Company from Marketing Unapproved New Drugs

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On January 30, 2015, and at the request of the U.S. Food and Drug Administration (FDA), a federal judge granted a consent decree of permanent injunction against Laclede, a U.S.-based manufacturer in connection with the marketing of unapproved new drugs. The permanent injunction prohibits Laclede from selling and distributing unapproved new drugs or misbranded drugs and devices. According to FDA’s announcement, Laclede had a long history of violations with the FDA. In 2012, FDA inspectors found numerous violations of the Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals and other issues surrounding the marketing and sale of unapproved new drugs.…
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FDA Guides on General Wellness and Low Risk Devices

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On January 20, 2015, the U.S. Food and Drug Administration (FDA) published a proposed guidance document regarding the FDA’s current position on low risk devices and general wellness products. This guidance document directs the Center for Devices and Radiological Health (CDRH) to deal with inquires from manufacturers asking whether or not their products qualify as “devices” under the Federal Food, Drug, and Cosmetic Act (FDCA). Devices are defined in section 201(h) of the FDCA as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is ...intended…
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