This useful guide includes chapters from FDA, FTC, marketing professionals, patient advocates, private attorneys and industry groups- it presents different issues and perspectives on the cutting ed...read more
This new 2012 edition is fully updated to reflect the recent amendments to the Federal Food, Drug, and Cosmetic Act by the Food and Drug Administration Safety and Innovation Act (FDASIA). Signed in...read more
Compilation of FDCA-Related Statutes, 2010 (Including Statutes Relating to Food and Medical Products; Regulation of Commerce; Enforcement and Criminal Sanctions; and Administrative Law) This valuab...read more
The international pharmacovigilance arena has become increasingly complex as emerging markets recognize the need to develop robust regulatory frameworks, while developed markets continue to grapple...read more
Puzzled by REMS? We have the answer for you! Pharmaceutical Risk Management: Practical Applications With a Foreword by Janet Woodcock, MD, Director of FDA’s Center for Drug Evaluation and...read more
This book is intended to provide individuals responsible for and participating in the due diligence process of a healthcare product or product company with a framework and mindset for maximizing th...read more
This book examines FDA's use of the Federal Food, Drug, and Cosmetic Act as a regulatory tool for bringing about change to public health policy. Citing landmark initiatives, this book documents FDA...read more
FDA: Century Of Consumer Protection commemorates the 100th anniversary of the enactment of the 1906 Pure Food and Drugs Act. This spirited and unprecedented book is the only book commemorating the ...read more
This Act, commonly referred to as “Hatch-Waxman”, is the single most important food and drug legislation enacted since the passage of the 1962 drug amendments. The statute recogn...read more