Regulation of Biological Products
| Author | : United States |
| Publisher | : |
| Total Pages | : 40 |
| Release | : 1956 |
| Genre | : Biological products |
| ISBN | : |
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Regulation Of Biological Products PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Regulation Of Biological Products PDF full book. Access full book title Regulation Of Biological Products.
Biologics Development
| Author | : Mark P. Mathieu |
| Publisher | : Parexel International Corporation |
| Total Pages | : 328 |
| Release | : 1993 |
| Genre | : Political Science |
| ISBN | : |
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Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
| Author | : Gloria Hall |
| Publisher | : |
| Total Pages | : |
| Release | : 2020-03-06 |
| Genre | : |
| ISBN | : 9781947493414 |
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Regulation of Biological Control Agents
| Author | : Ralf-Udo Ehlers |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 412 |
| Release | : 2011-02-03 |
| Genre | : Technology & Engineering |
| ISBN | : 9048136644 |
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This book presents a comprehensive compilation of registration requirements necessary for authorisation of biological control agents (viruses, bacteria, fungi, active substances of natural origin and semiochemicals) in OECD countries. It also reviews data requirements for invertebrate agents (insect, mites and nematodes) and provides proposals for harmonisation of the regulation process and guidelines for completion of application forms. Based on results of the EU REBECA Policy Support Action, which gathered experts from academia, regulation authorities and industry, risks and benefits of the specific agents were reviewed and proposals for a more balanced registration process elaborated, including recommendations for acceleration of the authorisation process and discussions on trade-off effects and policy impacts. All these aspects are covered in detail in this book, which points the way forward for enhanced utilisation of biological control agents.
Biologics Development
| Author | : Mark Mathieu |
| Publisher | : Barnett Educational Services / Chi |
| Total Pages | : 283 |
| Release | : 2004-01-01 |
| Genre | : Medical |
| ISBN | : 9781882615674 |
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This publication is the only text on Biologics Development and Regulation in the Post-CBER/CDER Consolidation Era. Completely revised and updated to address the transfer of therapeutic biological products to CDER, this all-new edition provides the most comprehensive and up-to-date analysis of the FDA's emerging processes for regulating and approving biological products. Written by CDER and CBER officials and industry experts, Biologics Development: A Regulatory Overview offers an expansive examination of the FDA's regulation of biologic products, from preclinical testing to post-marketing regulatory requirements, and from user fees to electronic submissions. Better yet, this new text provides the first detailed look inside the re-invented FDA that will regulate and approve today's biological products.
Safe and Effective Medicines for Children
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 432 |
| Release | : 2012-10-13 |
| Genre | : Medical |
| ISBN | : 0309225493 |
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The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
Rare Diseases and Orphan Products
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 442 |
| Release | : 2011-04-03 |
| Genre | : Medical |
| ISBN | : 0309158060 |
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Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Regulation of Biological Products
| Author | : National Institutes of Health (U.S.). Division of Biologics Standards |
| Publisher | : |
| Total Pages | : 23 |
| Release | : 1955 |
| Genre | : Biological products |
| ISBN | : |
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Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 118 |
| Release | : 2012-04-04 |
| Genre | : Medical |
| ISBN | : 0309222176 |
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The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.
Biologics, Biosimilars, and Biobetters
| Author | : Iqbal Ramzan |
| Publisher | : John Wiley & Sons |
| Total Pages | : 328 |
| Release | : 2021-02-03 |
| Genre | : Medical |
| ISBN | : 1119564654 |
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A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists
