Regulatory Writing: An Overview, Second Edition

The second edition of Regulatory Writing: An Overview presents a writer’s-eye view of regulatory documentation intended to help writers, reviewers, and readers of regulatory documentation to better understand the varied aims and audiences of these complex documents. Novice writers as well as seasoned professionals will benefit from this new edition. Regulatory Writing is an invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation. The authors have cited relevant guidelines, industry guidance, publication guides, and collaborative efforts to streamline, harmonize, and advance the production of high-quality regulatory documentation.

What's New?

Every chapter has been updated to reflect new regulations and guidance. Some of these changes were substantial, especially in light of the COVID-19 public health emergency.

• The clinical study reports chapter was updated to include new US guidance on study reporting requirements and carried this information forward to other documents, such as integrated summaries, that might be affected by the new requirements.
• The scope of the book was expanded to better reflect the shared nature of regulatory documentation and the goal that individual documents may be used in dossiers worldwide.
• New topics were added, including enhanced information about good documentation practices, accelerated filings, combination products, devices, safety update reporting and dossier maintenance.
• More examples were added to highlight requirements in Europe and the rest of the world, rather than concentrating only on US FDA requirements.
• New chapters were developed to provide an overview of the review process at regulatory authorities and to highlight further developments and future directions for the field.
• A new chapter on lay summaries was added, which is a requirement in the EU, and pairs with the existing chapter on pediatric investigation plans.