Featured Articles on Global & FDA Regulation
Discover everything you need to know about FSMA and its 10 crucial rules for gaining and maintaining FDA compliance within the food and beverage industry.
Explore the crucial distinctions between a Class I medical device, Class II, and Class III while understanding their characteristics and regulatory nuances.
Discover everything you need to know as an FSVP importer and the 8 simple steps to assure continued FSVP compliance and the safety of US public health.
Latest Global & FDA Compliance Articles
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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Learn how to prepare eCTD submissions for FDA and global markets. Get up to speed on version 4.0, lifecycle tips, and best practices for compliance success.
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