RAPS has just published the updated, 11th edition of Fundamentals of US Regulatory Affairs , the most extensive regulatory affairs textbook available, covering US regulations for pharmaceuticals, medical devices, biologics and related healthcare products. First published 20 years ago, the book has become an important reference for regulatory professionals and others working with healthcare products regulated by the US Food and Drug Administration (FDA) and other US agen...

The US Food and Drug Administration (FDA) on Wednesday unveiled new draft guidance to help sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) understand what information they’re now required to share with FDA on the marketing status of their brand and generic drugs. Thanks to the FDA Reauthorization Act of 2017 , drugmakers are required to provide additional information regarding the marketing status of approved drug products, includ...

The US Food and Drug Administration’s (FDA) Purple Book for biosimilars needs some modifications and new information to be more useful, pharmaceutical companies told FDA in recent comments. According to FDA, the Purple Book includes the date a biosimilar or biologic was licensed and whether FDA evaluated the biological product for reference product exclusivity. It also includes whether a biological product has been determined by FDA to be biosimilar to or interchangea...

Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max Sherman, the editor of RAPS’ recently published second edition of The Medical Device Validation Handbook . Unfortunately, many regulatory and quality professionals, and others involved in device compliance, lack the necessary knowledge and expertise. “People need a greater unders...

As part of efforts to increase transparency and generic drug competition, the US Food and Drug Administration (FDA) is publishing patent submission dates to help generic drug manufacturers determine the earliest date when they may be able to market new generics. FDA began collecting the patent submission date data in 2013, and the agency says there are about 4,000 patent records for which submission dates are available. The update is the result of a final rule fr...

This article discusses developing a "promotional claims compendium" to review pharmaceutical marketing materials. It highlights the advantages of using a compendium for a variety of purposes and the potential value it could bring to not only the review team, but the entire organization. Introduction Reviewing promotional materials is a necessity in the pharmaceutical industry. Rules and regulations implemented by the US Food and Drug Administration (FDA) regarding pro...

RAPS has published the updated, 10th edition of Fundamentals of US Regulatory Affairs , the most extensive reference available on regulatory affairs for pharmaceuticals, medical devices, biologics and other healthcare products intended for the US market. The book is an essential reference for anyone responsible for products that must comply with regulations from the US Food and Drug Administration (FDA) and other relevant US agencies. The first edition of US ...

This article discusses how Thailand's Ministry of Public Health (MOPH), Food and Drug Administration (Thai FDA) and a number of government and independent health agencies regulate drugs, both new and generic, as well as traditional, nonwestern medicines. Regulatory System Overview Thailand's health system is regulated by the MOPH and the Thai FDA in collaboration with a number of government and independent health agencies. The MOPH is responsible for all health-relate...

With the intent to cut back on the type of litigation that can delay the approval and marketing of generic drugs under 505(b)(2) applications and abbreviated new drug applications (ANDAs), the US Food and Drug Administration (FDA) on Wednesday released a final rule that revises and clarifies its regulations on a number of different parts of the pharmaceutical patent process. The 289-page final rule amends FDA’s regulations to facilitate better compliance with and enforce...

The US Food and Drug Administration (FDA) on Monday launched an improved web-based version of its publication on drugs approved on the basis of safety and effectiveness, more commonly known as the “Orange Book.” FDA's Orange Book is widely used in the regulatory community (and by doctors) for identifying which drug products are substitutable for one another, while FDA's Purple Book is list of all licensed biologics and biosimilars (the biological equivalent of the phar...

RAPS will be publishing the third edition of Fundamentals of International Regulatory Affairs later this year. We are looking for authors for chapters on general information, pharmaceuticals, biologics and other product types. All medical device chapters have been assigned. Outlines will be due 15 June 2016 and chapters will be due 1 September. If you are interested in participating in this project, please send your CV and the chapter(s) of interest to Pam Jones ...

RAPS is planning to publish a regulatory writing handbook later this year and is seeking contributing authors. Chapters will be due in late summer. If you or a colleague have expertise in any of the available topics and would be interested in sharing that knowledge, please contact Senior Editor Pam Jones at pjones@raps.org with the specific topic and a CV. Available topics are: Policies, Codes and Guidance for Industry Overview of ICH guidelines for regulator...