Elaine S Waller and Nancy L Kercher

Regulatory Authorities and the Laws 149

Protecting the Public Health 149

Advancing the Public Health 150

Helping the Public Get Accurate, Science-Based Information 150

Regulatory Development Strategies 157

Fast-Track Program 157

Priority Review 157

Rolling Submission 157

Accelerated Approval 158

Orphan Drugs 158

Rx to OTC Switch 159

Submissions to Regulatory Authorities 160

Product Review 165

Package Insert 167

Advertising 167

Postapproval Maintenance 168

Compliance/Quality Assurance 171

General References 177

The discipline of regulatory affairs integrates the scientific information obtained during the development of a drug product, the marketing opportunities and competitive landscape, protection of the intellectual property surrounding a drug product, and the compliance efforts of a pharmaceutical company. It requires knowledge and, most importantly, interpretation of the most current requirements of regulatory authorities around the world.

It is the responsibility of the regulatory affairs professional to represent their interpretation of the regulatory requirements to their colleagues in such a way that they constructively facilitate, not obstruct, the development of a drug product. The critical skills to being a successful regulatory affairs professional include ability to think strategically; being able to integrate the diverse aspects of drug development, whether they are related to chemistry, manufacturing, pharmacology, clinical, legal, or marketing. Additionally, it is necessary to balance patient care, science, and business needs of the product and company; educate internal staff, both scientists and marketers about the regulatory requirements and vagaries of product development and marketing; and effectively communicate and negotiate with regulatory authorities. For individuals who are more oriented to breadth of a broad subject (i.e., drug development and commercialization) versus the depth of an individual piece (i.e., toxicology) of that broad subject, regulatory affairs is an ideal discipline.

The chapter outline covers all the major aspects of regulatory affairs, with a focus on the environment in the United States and the Food and Drug Administration (FDA). Although the regulatory and intellectual property laws are different outside the United States, and some registration processes are different, fundamentally the discipline of regulatory affairs is practiced very similarly around the world. Having an understanding of the process and requirements in the United States provides an excellent model for the processes and requirements in the developed world. In response to the growth of global pharmaceutical and biotechnology companies, there have been efforts by major countries to harmonize regulatory requirements. Where appropriate, those harmonization efforts are discussed to provide a global perspective.

The chapter begins with the basis for the regulatory authority of the FDA and a brief orientation to the complex organization that constitutes the agency. It then follows a model chronology of the role of regulatory affairs during the drug development, approval, and postapproval process, starting with the development of a regulatory strategy designed to optimize the regulatory approval and marketability of the drug product. This is followed with a description of the process of submitting applications to the FDA for both the investigational phase and the approval phase of a product. The steps of the approval process and the interactions with the FDA during product approval are described. The regulatory obligations continue once a product is approved, as there continue to be regulatory requirements for as long as the product is made commercially available.

Underlying the entire process are requirements for compliance with FDA regulations in the way the pharmaceutical industry conducts its business, whether that be in the manufacture of a drug product, the way in which animal and human trials are conducted, or the commercial promotion of a product.

Finally, the chapter concludes with some of the enduring controversies in regulatory affairs. These controversies drive pharmaceutical companies and the FDA, whether independently or in cooperation, to try to address the issues that surface in these controversies in a balanced, risk-based approach.

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