Discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.
An examination of US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. It recommends pragmatic ways to interpret and comply with FDA current good manufacturing practice (CGMP) regulation and related criteria.
Présentation de l'éditeur : "Patents, including pharmaceutical patents, enjoy extended protection for twenty years under the TRIPs Agreement. The Agreement has resulted in creating a two-tier system of the World Trade Organisation Member States, and its implementation has seen t…
This book explores the current difficulties with pharmaceutical patents in the post-TRIPS era and suggests how working with international organizations may improve access to affordable medicines in developing countries. Patents, including pharmaceutical patents, enjoy extended p…
"Should we legalize marijuana? If we legalize, what in particular should be legal? Just possessing marijuana and growing your own? Selling and advertising? If selling becomes legal, who gets to sell? Corporations? Co-ops? The government? What regulations should apply? How high s…
"Should we legalize marijuana? If we legalize, what in particular should be legal? Just possessing marijuana and growing your own? Selling and advertising? If selling becomes legal, who gets to sell? Corporations? Co-ops? The government? What regulations should apply? How high s…
"This book provides a synthesized look at the pressures that are impacting today's markets, including trade liberalization, harmonization initiatives between governments, increased aid activities to low-and middle-income countries, and developing pharmaceutical sectors in China …
During much of the nineteenth century, physicians and pharmacists alike considered medical patenting and the use of trademarks by drug manufacturers unethical forms of monopoly; physicians who prescribed patented drugs could be, and were, ostracized from the medical community. I…
"Drawing on a wealth of previously overlooked archival material, 'Medical Monopoly' combines legal, medical, and business history to offer a sweeping new interpretation of the origins of the complex and often troubling relationship between the pharmaceutical industry and medical…