Category: Issue 430
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FDA Releases Guidance on Veterinary Medicines
The Food and Drug Administration (FDA) has announced the availability of industry guidance concerning drugs for veterinary care. The guidance provides “recommendations on what documentation to submit to support the CMC [Chemistry, Manufacturing, and Controls] information for fermentation-derived intermediates, drug substances, and related drug products for veterinary medicinal use.” Noting that a variety of products are…
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FDA Issues Industry Guidance on Testing Procedures for Salmonella
The Food and Drug Administration (FDA) has released industry guidance addressing the testing procedures for Salmonella species “in human foods and direct-human-contact animal foods.” Applicable to firms that manufacture, process, pack, or hold these products for distribution to consumers, institutions or food processors, the guidance also discusses the interpretation of test results when the presence…
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FDA Warns Company Making and Selling “Inhalable” Caffeine Product
The Food and Drug Administration issued a warning letter to BreathableFoods, Inc., which makes AeroShot Energy®, an “inhalable”caffeine product, on March 5, 2012. According to the agency, the AeroShot product is misbranded because it is labeled as intended for inhalation while the company’s Website indicates that the product is intended for ingestion. “Your labeling is…