FDA Regulatory Affairs for Professionals

The FDA Regulatory Affairs guide serves as a roadmap for the development of prescription drugs, biologics, and medical devices in the United States. Written in clear and concise language, free from industry jargon, the guide demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more.

The Third Edition of this highly successful publication examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing. It includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL, focusing on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements.

Moreover, the guide provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V. It explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions.

Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that's broadly useful to both business and academia.

The guide's harmonization of US and international regulations on drug, biologics, and device development, research, manufacturing, and marketing is a valuable asset for companies and researchers navigating the complex regulatory landscape. The contributions from experts at organizations like the FDA, NIH, and PAREXEL provide authoritative insights into the nuances of the regulatory process.

The guide's focus on the NDA process, cGMPs, GCPs, quality system compliance, and documentation requirements equips readers with a comprehensive understanding of the key elements involved in obtaining FDA approval. The updates on FDASIA, PDUFA V, and current inspection and enforcement procedures further enhance the guide's utility in staying abreast of the evolving regulatory environment.

The collaboration between an industry leader and an academic expert ensures that the guide offers a balanced perspective, catering to the needs of both business and academic stakeholders. The compilation of selected US laws and regulations, coupled with the straightforward commentary on the FDA product approval process, makes the guide a valuable resource for a wide range of audiences, from pharmaceutical and medical device companies to researchers and policymakers.

In summary, the FDA Regulatory Affairs guide is an indispensable resource for navigating the complex regulatory landscape in the United States, providing a clear and concise roadmap for the development of prescription drugs, biologics, and medical devices. Its blend of expert insights, regulatory updates, and practical guidance makes it a must-have for anyone involved in the life sciences industry.

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