Compliance Quality Assurance

Compliance with the regulations, and the assurance that a company is in compliance, underlies all the regulatory aspects that have been discussed thus far in this chapter. The FDA requires that any drug or biologic product, whether at the investigational stage or being marketed, is manufactured, studied, and marketed in accordance with its regulations, and the FDA has substantial power to enforce their compliance to the regulations. Even the most innovative product for a highly unmet medical...

Acknowledgments

The members of the editorial board of this book have been professional associates in health care and research in the industry and academia during the editor's career, as well as friends. Each brings his own base of experience and talents to this scholarly work. Their advice and engagement as editorial advisors and authors have enriched the content and were indispensable to me as the editor. The authors comprise 24 talented group of researchers, clinicians, and educators in health care, both...

Helping the Public Get Accurate Science Based Information

The FDA is responsible for regulating the communications between the pharmaceutical, biotechnology, and medical device companies and the prescribing physicians, other providers, institutions, and patients who use their products. First and foremost, FDA fulfills this mission through approving the language in the package inserts of all drug and biological products, and regulating the educational and advertising materials for drug products. FDA communicates directly to the public through press...

Elaine S Waller and Nancy L Kercher

Regulatory Authorities and the Laws Protecting the Public Health Advancing the Public Helping the Public Get Accurate, Science-Based Information Regulatory Development Strategies Fast-Track Priority Review Rolling Accelerated Approval Orphan Drugs Rx to OTC Submissions to Regulatory Authorities Product Review Package Advertising Postapproval Maintenance Compliance Quality Assurance General References The discipline of regulatory affairs integrates the scientific information obtained during the...

Editors and Authors

The book is authored by a multidisciplinary team of researchers, clinicians, and marketers from industry and the medical pharmaceutical community. They collectively have done extensive work in drug development, measured by the many product applications prepared and ushered through regulatory authorities, by scope and quality of institutions and companies at which they worked, by number of years devoted to research and product development, and by hundreds of publications. The experience base in...

Rx to OTC Switch

Dozens of products have been switched from prescription status to being available over-the-counter OTC without a prescription Fig. 7.13 . In order for a drug to be switched, the product must be used to treat or prevent symptoms in a disease where physician oversight is not necessary. The patient must also be able to self-diagnose the condition being treated. Sinus congestion, headache, pain, upset stomach, and itching are examples of symptoms a patient can recognize. Drugs that must be...

Value of PKPD

In drug development, the ADME processes of a compound are experimentally determined Figs. 6.2 and 6.3 . Absorption studies are conducted to answer the basic question whether the drug can reach the systemic circulation from the site of administration. There are several factors that can influence the absorption of the drug after oral administration. The drug needs to have a high solubility and high permeability in order to be absorbed adequately. A Biopharmaceutics Classification System BCS was...