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Posts tagged ‘FDA Drugs’

On January 20, 2015, the U.S. Food and Drug Administration (FDA) added another company, Chaga Mountain, Inc., to its list of warning letters that address drug claims made for products marketed as cosmetics.  According to FDA, “a product intended to diagnose, mitigate, treat, or prevent disease, or to affect the structure or function of the […]

In 2009, the U.S. Food and Drug Administration (FDA) launched a Mini-Sentinel pilot program. The program was launched as part of the Sentinel Initiative, which aims to create a new and improved system of tracking the safety of FDA-regulated drugs and medical devices.  Five years later, the Mini-Sentinel program is transitioning into a full-scale operation […]

The U.S. Food and Drug Administration (FDA) requires all drug facilities that manufacture, prepare, propagate, compound, or process drugs for commercial distribution in the United States to renew their registrations every year between October 1 and December 31.  According to FDA’s Drug Establishments Current Registration Site, there were 10,383 drug facilities listed in FDA’s drug […]

In November 2014, the U.S. Food and Drug Administration published “Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration.” The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in July 2012, directed the Secretary of Health and Human Services (who then delegated FDA) to specify a UFI system […]

Under the Food and Drug Administration Safety and Innovation Act (FDASIA), the U.S. Food and Drug Administration (FDA) may deem a drug adulterated if that drug is “manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an […]

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