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"Pharmaceutical industry Law and legislation United States."
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Pharmaceutical manufacturing handbook
With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
eBook
Drug wars : how big pharma raises prices and keeps generics off the market
\"While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs\"-- Provided by publisher.
Book
The Myth of the Free Market for Pharmaceuticals
The Myth of the Free Market for PharmaceuticalsThe U.S. pharmaceutical market has always been influenced by government. The 2022 Inflation Reduction Act is the latest policy aiming to improve access and affordability while supporting innovation.
Journal Article
Reputation and power
The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power?Reputation and Powertraces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints.
Daniel Carpenter describes how the FDA cultivated a reputation for competence and vigilance throughout the last century, and how this organizational image has enabled the agency to regulate an industry as powerful as American pharmaceuticals while resisting efforts to curb its own authority. Carpenter explains how the FDA's reputation and power have played out among committees in Congress, and with drug companies, advocacy groups, the media, research hospitals and universities, and governments in Europe and India. He shows how FDA regulatory power has influenced the way that business, medicine, and science are conducted in the United States and worldwide. Along the way, Carpenter offers new insights into the therapeutic revolution of the 1940s and 1950s; the 1980s AIDS crisis; the advent of oral contraceptives and cancer chemotherapy; the rise of antiregulatory conservatism; and the FDA's waning influence in drug regulation today.
Reputation and Powerdemonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested.
eBook
Confirmatory Trials of Accelerated Approval Drugs — Will Imposing Fines Reduce Delays?
Confirmatory Trials of Accelerated Approval DrugsIn order to ensure timely testing of drugs that have been granted accelerated approval, the FDA can impose civil monetary penalties on dilatory manufacturers — but has never done so.
Journal Article
The US regulatory and pharmacopeia response to the global heparin contamination crisis
The contamination of the widely used lifesaving anticoagulant drug heparin in 2007 has drawn renewed attention to the challenges that are associated with the characterization, quality control and standardization of complex biological medicines from natural sources. Heparin is a linear, highly sulfated polysaccharide consisting of alternating glucosamine and uronic acid monosaccharide residues. Heparin has been used successfully as an injectable antithrombotic medicine since the 1930s, and its isolation from animal sources (primarily porcine intestine) as well as its manufacturing processes have not changed substantially since its introduction. The 2007 heparin contamination crisis resulted in several deaths in the United States and hundreds of adverse reactions worldwide, revealing the vulnerability of a complex global supply chain to sophisticated adulteration. This Perspective discusses how the US Food and Drug Administration (FDA), the United States Pharmacopeial Convention (USP) and international stakeholders collaborated to redefine quality expectations for heparin, thus making an important natural product better controlled and less susceptible to economically motivated adulteration.
Journal Article
Evolution of a regulatory framework for pharmaceuticals derived from genetically modified plants
The use of genetically modified (GM) plants to synthesize proteins that are subsequently processed, regulated and sold as pharmaceuticals challenges two very different established regulatory frameworks, one concerning GM plants and the other covering the development of biotechnology-derived drugs. Within these regulatory systems, specific regulations and guidelines for plant-made pharmaceuticals (PMPs) – also referred to as plant-derived pharmaceuticals (PDPs) – are still evolving. The products nearing commercial viability will ultimately help to road test and fine-tune these regulations, and might help to reduce regulatory uncertainties. In this review, we summarize the current state of regulations in different countries, discuss recent changes and highlight the need for further regulatory development in this burgeoning, new industry. We also make the case for the harmonization of international regulations.
Journal Article
Rupturing the Temporality of Pharmaceutical Patents: A Sketch for a New Temporal Economy of Pharmaceutical Markets
The objective of this paper is to devise a set of principles and practices that can break with the temporalities of current pharmaceutical markets, and on this basis sketch a social contract for a new (temporal) political economy of pharmaceuticals. Pharmaceutical futures are, in my analysis, doubly predetermined by standard arguments around pharmaceutical patenting and pricing: they are narrated as a consequence of “past” investments to be recouped, but they are also predetermined on a particular “future perfect,” where past investment successes and promises to maintain the status quo determine the course of action of future investors. This double colonization of the future, in my analysis, eliminates any scope for meaningful change. Making this often implicit temporality of pharmaceutical markets explicit may allow to better take into account multiple temporalities in regulating this space. Chiefly among them are patients’ temporalities, which typically get overridden by the peculiar timelines of patent-based markets. The mRNA vaccine market serves as an illustration of the theoretical arguments raised, and I discuss four strategies that could lead toward a new temporal political economy of pharmaceutical markets: temporally sensitive policymaking; decolonizing the future through narrower patents; delinking patents from their asset condition; and pharmaceutical commons.
Journal Article
Regulatory And Cost Barriers Are Likely To Limit Biosimilar Development And Expected Savings In The Near Future
In March 2010 Congress established an abbreviated Food and Drug Administration approval pathway for biosimilars-drugs that are very similar but not identical to a reference biological product and cost less. Because bringing biosimilars to the market currently requires large investments of money, fewer biosimilars are expected to enter the biologics market than has been the case with generic drugs entering the small-molecule drug market. Additionally, given the high regulatory hurdles to obtaining interchangeability-which would allow pharmacists to substitute a biosimilar for its reference product, subject to evolving state substitution laws-most biosimilars will likely compete as therapeutic alternatives instead of as therapeutic equivalents. In other words, biosimilars will need to compete with their reference product on the basis of quality; price; and manufacturer's reputation with physicians, insurers, and patient groups. Biosimilars also will face dynamic competition from new biologics in the same therapeutic class-including \"biobetters,\" which offer incremental improvements on reference products, such as extended duration of action. The prospects for significant cost savings from the use of biosimilars appear to be limited for the next several years, but their use should increase over time because of both demand- and supply-side factors.
Journal Article