Do food, medical devices, drugs, and cosmetics need FDA approval? Read our guide on how to get FDA approval for your regulated product.

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Understand GDUFA user fees, inspection rules, and compliance tips for generic drug makers and CMOs. Avoid delays and secure faster US market access.

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A complete guide to OMUFA: Learn how OTC drug makers can manage FDA facility fees, OMORs, exemptions, and stay compliant under the CARES Act framework.

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Learn how the FDA’s Red 3 ban impacts food and drug makers. Discover compliance deadlines, reformulation challenges, and key industry insights.

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Ensure FDA compliance with Adverse Event Reporting (AER) for pharmaceuticals & dietary supplements. Avoid penalties & protect your U.S. market access.

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Ensure ingredient and formulation compliance for pharmaceutical, medical device, & food exports from India.

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