Tag: How to get US FDA approval in India?
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US FDA ANDA Drug Registration: Regulatory Pathway for Generic Medicines
The Abbreviated New Drug Application (ANDA) is the approval route used for generic medicines in the United States. Companies that wish to market a generic drug must submit an ANDA to the U.S. Food and Drug Administration (FDA) demonstrating that their product is equivalent to a previously approved reference listed drug (RLD). US FDA ANDA…
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US FDA Cosmetic Registration: How Cosmetic Brands Can Achieve US Compliance Without Delays
Selling cosmetics in the United States is a major opportunity but it comes with clear regulatory expectations. Brands that understand FDA cosmetic registration early move faster, clear customs smoothly, and build trust with buyers. Those that misunderstand it often face shipment holds, relabeling costs, or rejected listings. What FDA Cosmetic Registration Really Means FDA cosmetic…