Featured Drugs Articles
Secure your proprietary data with Drug Master File submissions to the FDA. Trust Registrar Corp for expert assistance and confidentiality.
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Easily navigate FDA regulations for OTC human drugs with these expert insights into registration, listing, & marketing compliance.
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Latest Drugs Compliance Articles
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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Learn how to navigate the FDA’s 505B1 NDA process—from data requirements to approval timelines, labeling, and compliance. Avoid delays with expert guidance.
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Learn how to leverage the 505B2 NDA pathway for faster FDA approval. Use existing data, reduce costs, and gain exclusivity for differentiated drug products.
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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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