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Author: Martin A. Voet
Publisher: BrownWalker Press
ISBN: 1627347461
Category : Law
Languages : en
Pages : 240
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Book Description
This Sixth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.
Author: Martin A. Voet
Publisher: BrownWalker Press
ISBN: 1627347461
Category : Law
Languages : en
Pages : 240
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Book Description
This Sixth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.
Author:
Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129
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Book Description
Author:
Publisher: U.S. Government Printing Office
ISBN:
Category : Business & Economics
Languages : en
Pages : 94
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Book Description
Author: Kung-Chung Liu
Publisher: Springer Nature
ISBN: 981138102X
Category : Law
Languages : en
Pages : 513
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Book Description
This open access book analyses intellectual property codification and innovation governance in the development of six key industries in India and China. These industries are reflective of the innovation and economic development of the two economies, or of vital importance to them: the IT Industry; the film industry; the pharmaceutical industry; plant varieties and food security; the automobile industry; and peer production and the sharing economy. The analysis extends beyond the domain of IP law, and includes economics and policy analysis. The overarching concern that cuts through all chapters is an inquiry into why certain industries have developed in one country and not in the other, including: the role that state innovation policy and/or IP policy played in such development; the nature of the state innovation policy/IP policy; and whether such policy has been causal, facilitating, crippling, co-relational, or simply irrelevant. The book asks what India and China can learn from each other, and whether there is any possibility of synergy. The book provides a real-life understanding of how IP laws interact with innovation and economic development in the six selected economic sectors in China and India. The reader can also draw lessons from the success or failure of these sectors.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309468086
Category : Medical
Languages : en
Pages : 235
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Book Description
Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Author: Robin Feldman
Publisher: Cambridge University Press
ISBN: 1107168481
Category : Business & Economics
Languages : en
Pages : 165
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Book Description
In this book, Feldman and Frondorf explain how companies employ strategies that block generic medicines from the market and keep prices high.
Author: Holly Fernandez Lynch
Publisher: Columbia University Press
ISBN: 0231540078
Category : Business & Economics
Languages : en
Pages : 499
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Book Description
In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.
Author: Michael Gruss
Publisher: John Wiley & Sons
ISBN: 352734635X
Category : Science
Languages : en
Pages : 578
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Book Description
Solid State Development and Processing of Pharmaceutical Molecules A guide to the lastest industry principles for optimizing the production of solid state active pharmaceutical ingredients Solid State Development and Processing of Pharmaceutical Molecules is an authoritative guide that covers the entire pharmaceutical value chain. The authors—noted experts on the topic—examine the importance of the solid state form of chemical and biological drugs and review the development, production, quality control, formulation, and stability of medicines. The book explores the most recent trends in the digitization and automation of the pharmaceutical production processes that reflect the need for consistent high quality. It also includes information on relevant regulatory and intellectual property considerations. This resource is aimed at professionals in the pharmaceutical industry and offers an in-depth examination of the commercially relevant issues facing developers, producers and distributors of drug substances. This important book: Provides a guide for the effective development of solid drug forms Compares different characterization methods for solid state APIs Offers a resource for understanding efficient production methods for solid state forms of chemical and biological drugs Includes information on automation, process control, and machine learning as an integral part of the development and production workflows Covers in detail the regulatory and quality control aspects of drug development Written for medicinal chemists, pharmaceutical industry professionals, pharma engineers, solid state chemists, chemical engineers, Solid State Development and Processing of Pharmaceutical Molecules reviews information on the solid state of active pharmaceutical ingredients for their efficient development and production.
Author: Subba Rao Chaganti
Publisher: BSP Books
ISBN: 9390211646
Category : Business & Economics
Languages : en
Pages : 547
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Book Description
The empowered patients, new-age technologies such as artificial intelligence (AI), machine learning (ML), big data analytics, real-world data and evidence, blockchain, electronic health records (EHRs), digital therapeutics, cloud computing, and innovative marketing frameworks like design thinking, customer journey mapping, omnichannel, closed-loop marketing, personalization and agile ways of working are transforming the way healthcare is delivered, affecting the pharmaceutical industry. Additionally, big tech companies such as Amazon, Alphabet, Apple, and Microsoft are disrupting by offering non-pharmacological solutions with innovative digital technologies to provide a seamless customer experience in the patient journey. The recent COVID-19 pandemic added rocket fuel to the digital transformation of the pharmaceutical industry, changing the entire model of care and ingraining telemedicine in the healthcare ecosystem. Digital Transformation has become inevitable and imminent. Therefore, pharma must reimagine its entire strategy and embrace digital transformation to succeed in this rapidly changing marketing environment that is becoming increasingly complex. Reimagine Pharma Marketing: Make It Future-Proof introduces all these technology frameworks. Additionally, the book presents one hundred and two case studies showing how some of the leading pharmaceutical companies are applying the new age technologies and marketing frameworks effectively. It can be your single-source guidebook unraveling the future so you can manage it!Contents: 1. Reimagine Everything — Reimagine Every Element of Pharmaceutical Marketing Mix 2. Reimagine the Technology— How Pharma Can Harness the Power of New and Emerging Technologies 3. Reimagine Stakeholder Engagement—Winning with New Rules of Engagement 4. The Future of Pharma—A Look into the Crystal Ball Epilogue You’re Gonna Need a Bigger Boat!
Author: United States. Congress. Senate. Committee on the Judiciary
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 184
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Book Description
