Looking to clarify its expectations on manufacturer responses following inspections, the FDA earlier this year unveiled, for ...
WASHINGTON -- The US Food and Drug Administration said Wednesday it will be lowering its targets for sodium content in processed, packaged, and prepared foods, but not to levels recommended for ...
The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
The FDA released draft guidance indicating it may approve certain biosimilars without requiring a comparative efficacy study (CES), traditionally a costly and time-intensive step. Instead, advances in ...
The FDA has quietly proposed legislation that would give it more authority to deem drugs misbranded in pharma DTC ads. But ...
The US Food and Drug Administration (FDA) has released a draft guidance document aimed at setting impurity limits for antibiotics produced through fermentation or semi-synthetic methods.
The FDA has issued detailed guidance on decentralized clinical trials (DCTs), clarifying operational expectations for remote consent, telehealth, and data integrity, while AI and data science tools ...
The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good ...
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