Long Acting Drug Delivery Systems Pharmaceutical Clinical And Regulatory Aspects

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Long-Acting Drug Delivery Systems

Author : Eneko Larraneta
Publisher : Elsevier
ISBN 13 : 0128217499
Total Pages : 392 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Long-Acting Drug Delivery Systems by : Eneko Larraneta

Download or read book Long-Acting Drug Delivery Systems written by Eneko Larraneta and published by Elsevier. This book was released on 2021-09-23 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: Long-Acting Drug Delivery Systems: Pharmaceutical, Clinical, and Regulatory Aspects offers a comprehensive overview of the technical, clinical, regulatory and industrial perspectives on these drug delivery systems. The book follows a sequential order, beginning with the current technical state-of-the-field and moving on to more clinical, industrial and regulatory topics. Opening chapters describe the current needs and potential applications of implantable and long-acting therapeutic approaches. The book goes on to describe established and novel long-acting systems, with a focus on the materials used to prepare these systems and their biocompatibility. Importantly, applied topics such as scale-up manufacturing, products under clinical trials and regulatory aspects are covered, offering the reader a holistic view of this rapidly growing field. Brings together technical, clinical, regulatory and industrial perspectives for a complete overview of long acting and implantable drug delivery systems Provides up-to-date coverage of established and novel long-acting and implantable drug delivery systems, both in development and actively in use Appeals to a broad readership, including materials scientists, pharmaceutical scientists, biomedical engineers, clinicians and regulatory experts

Long-Acting Drug Delivery Systems: Pharmaceutical, Clinical, and Regulatory Aspects

Author : Eneko Larrañeta
Publisher : Woodhead Publishing
ISBN 13 : 0128217596
Total Pages : 394 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Long-Acting Drug Delivery Systems: Pharmaceutical, Clinical, and Regulatory Aspects by : Eneko Larrañeta

Download or read book Long-Acting Drug Delivery Systems: Pharmaceutical, Clinical, and Regulatory Aspects written by Eneko Larrañeta and published by Woodhead Publishing. This book was released on 2021-09-21 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: Long-Acting Drug Delivery Systems: Pharmaceutical, Clinical, and Regulatory Aspects

Long Acting Injections and Implants

Author : Jeremy C. Wright
Publisher : Springer Science & Business Media
ISBN 13 : 1461405548
Total Pages : 556 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Long Acting Injections and Implants by : Jeremy C. Wright

Download or read book Long Acting Injections and Implants written by Jeremy C. Wright and published by Springer Science & Business Media. This book was released on 2012-01-29 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt: Long acting injections and implants improve therapy, enhance patient compliance, improve dosing convenience, and are the most appropriate formulation choice for drugs that undergo extensive first pass metabolism or that exhibit poor oral bioavailability. An intriguing variety of technologies have been developed to provide long acting injections and implants. Many considerations need to go into the design of these systems in order to translate a concept from the lab bench to actual therapy for a patient. This book surveys and summarizes the field. Topics covered in Long Acting Injections and Implants include the historical development of the field, drugs, diseases and clinical applications for long acting injections and implants, anatomy and physiology for these systems, specific injectable technologies (including lipophilic solutions, aqueous suspensions, microspheres, liposomes, in situ forming depots and self-assembling lipid formulations), specific implantable technologies (including osmotic implants, drug eluting stents and microfabricated systems), peptide, protein and vaccine delivery, sterilization, drug release testing and regulatory aspects of long acting injections and implants. This volume provides essential information for experienced development professionals but was also written to be useful for scientists just beginning work in the field and for others who need an understanding of long acting injections and implants. This book will also be ideal as a graduate textbook.

Drug Delivery Aspects

Author : Ranjita Shegokar
Publisher : Elsevier
ISBN 13 : 0128212225
Total Pages : 266 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Drug Delivery Aspects by : Ranjita Shegokar

Download or read book Drug Delivery Aspects written by Ranjita Shegokar and published by Elsevier. This book was released on 2020-04-13 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Delivery Aspects reviews additional features of drug delivery systems, along with the standard formulation development, like preclinical testing, conversion into solid dosage forms, roles of excipients and polymers used on stability and sterile processing. There is a focus on formulation engineering and related large scale (GMP) manufacturing, regulatory, and functional aspects of drug delivery systems. A detailed discussion on biologics and vaccines gives insights to readers on new developments in this direction. The series Expectations and Realities of Multifunctional Drug Delivery Systems examines the fabrication, optimization, biological aspects, regulatory and clinical success of wide range of drug delivery carriers. This series reviews multifunctionality and applications of drug delivery systems, industrial trends, regulatory challenges and in vivo success stories. Throughout the volumes discussions on diverse aspects of drug delivery carriers, such as clinical, engineering, and regulatory, facilitate insight sharing across expertise area and form a link for collaborations between industry-academic scientists and clinical researchers. Expectations and Realities of Multifunctional Drug Delivery Systems connects formulation scientists, regulatory experts, engineers, clinical experts and regulatory stake holders. The wide scope of the book ensures it as a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about drug delivery systems. Encompasses engineering and large-scale manufacturing of nanocarriers Considers preclinical, regulatory and ethical guidelines on nanoparticles Contains in-depth discussions on delivery of biologics, vaccines and sterilisation Industrial view on solid dispersions, milling techniques

Long Acting Injections and Implants

Author :
Publisher : Springer
ISBN 13 : 9781461405559
Total Pages : 576 pages
Book Rating : 4.4/5 (55 download)

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Book Synopsis Long Acting Injections and Implants by :

Download or read book Long Acting Injections and Implants written by and published by Springer. This book was released on 2012-01-29 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Delivery of Drugs

Author : Ranjita Shegokar
Publisher : Elsevier
ISBN 13 : 0128177772
Total Pages : 242 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Delivery of Drugs by : Ranjita Shegokar

Download or read book Delivery of Drugs written by Ranjita Shegokar and published by Elsevier. This book was released on 2020-02-01 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: Delivery of Drugs: Expectations and Realities of Multifunctional Drug Delivery Systems, Volume Two examines the formulation of micro-nanosized drug delivery systems and recaps opportunities for using physical methods to improve efficacy via mechano-, electroporation. The book highlights innovative delivery methods like PIPAC, including discussions on the regulatory aspects of complex injectables. Written by a diverse range of international researchers from industry and academia, the chapters examine specific aspects of characterization and manufacturing for pharmaceutical applications as well as regulatory and policy aspects. This book connects formulation scientists, regulatory experts, engineers, clinical experts and regulatory stakeholders. This level of discussion makes it a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about the status of drug delivery systems. Delivery of Drugs examines the fabrication, optimization, scale-up, biological aspects, regulatory and clinical success of various micro and nano drug delivery systems. The volume covers site and organ specific targeting approaches, technologies used in preparation of micro - nanoparticles, challenges of complex type of drug delivery forms and role of physical methods in achieving targeted drug effect. Written by a diverse range of international researchers the chapters examine the specific aspects of characterization and manufacturing of drug delivery system for pharmaceutical application and its regulatory aspects. The series Expectations and Realities of Multifunctional Drug Delivery Systems examines the fabrication, optimization, biological aspects, regulatory and clinical success of wide range of drug delivery carriers. This series reviews multifunctionality and applications of drug delivery systems, industrial trends, regulatory challenges and in vivo success stories. Throughout the volumes discussions on diverse aspects of drug delivery carriers, such as clinical, engineering, and regulatory, facilitate insight sharing across expertise area and form a link for collaborations between industry-academic scientists and clinical researchers. Expectations and Realities of Multifunctional Drug Delivery Systems connects formulation scientists, regulatory experts, engineers, clinical experts and regulatory stake holders. The wide scope of the book ensures it as a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about drug delivery systems.

Controlled Release Veterinary Drug Delivery

Author : M.J. Rathbone
Publisher : Elsevier
ISBN 13 : 9780080529974
Total Pages : 392 pages
Book Rating : 4.5/5 (299 download)

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Book Synopsis Controlled Release Veterinary Drug Delivery by : M.J. Rathbone

Download or read book Controlled Release Veterinary Drug Delivery written by M.J. Rathbone and published by Elsevier. This book was released on 2000-07-20 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many controlled release veterinary drug delivery systems (CRVDDS) are presently in use, and recently there has been a host of new CRVDDS within veterinary medicine. The challenges of this area of drug delivery arise from the unique anatomy and physiology of the target animal, the cost constraints associated with the value of the animal being treated and the extended periods of time that delivery must be sustained for (often measured in months). The purpose of this book is to introduce the reader to the unique opportunities and challenges of the field of CRVDDS and to explain and discuss the basic controlled release principles underlying the development of CRVDDS. Its aim is to provide an overview of many of the areas where CRVVDS have application, and to highlight the opportunities and prospects for controlled release technology in the veterinary field. Controlled Release Veterinary Drug Delivery comprises chapters that provide workers in the field (and those interested in this area) with information on the design, development and assessment of a variety of CRVDDS. The book contains chapters that describe the relevant animal physiological and anatomical considerations alongside descriptions of current and emerging controlled release delivery systems for a variety of routes for drug delivery, and present overviews on the physical and chemical assessment of veterinary controlled release delivery systems. The veterinary area is abound with opportunities for the development of controlled release drug delivery technologies. It is an area of medicine that is open to the acceptance of novel drug delivery devices, and which readily encompasses the use of novel routes of administration. It is an area of many unmet needs, most of which offer opportunities and unique challenges for the innovative formulation scientist to provide solutions. This book will provide an insight into the biological, clinical and pharmaceutical challenges that face the formulation scientist in this interesting and diverse area of research.

Modern Methods of Clinical Investigation

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309042860
Total Pages : 241 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Modern Methods of Clinical Investigation by : Institute of Medicine

Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Nanoarchitectonics for Brain Drug Delivery

Author : Anurag Kumar Singh
Publisher : CRC Press
ISBN 13 : 1003851843
Total Pages : 381 pages
Book Rating : 4.0/5 (38 download)

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Book Synopsis Nanoarchitectonics for Brain Drug Delivery by : Anurag Kumar Singh

Download or read book Nanoarchitectonics for Brain Drug Delivery written by Anurag Kumar Singh and published by CRC Press. This book was released on 2024-02-22 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses basics of brain diseases and the role of nanobiotechnology in existing treatment options for neurodegenerative disorders. It begins with an overview of brain diseases and the need for novel drug-delivery approaches. It highlights the current route for the intranasal advanced drug-delivery systems for brain diseases. It also discusses innovative categories of drug-delivery systems, including mesoporous silica nanoparticles, polymeric nanocarriers, and lipid-based nanocarriers through multi-responsive DDSs and their implications in brain disorders. Features: Includes an overview of brain diseases and highlights the need for novel drug-delivery approaches Focuses on theoretical aspects of advanced drug-delivery systems for brain diseases including challenges and progress in nose-to-brain delivery Provides an overview of technological approaches and their implications for neurodegenerative disorders, central nervous system (CNS), and brain drug delivery in brain cancer Discusses key advances in the development of polymer nanoparticles for drug delivery to the CNS Reviews the role of herbal medicines and naturally derived polymeric nanoparticle for the treatment of neurodegenerative disorders This book is aimed at graduate students and researchers in biomedical engineering, biotechnology, drug delivery, and neurology.

Modeling and Control of Drug Delivery Systems

Author : Ahmad Taher Azar
Publisher : Academic Press
ISBN 13 : 0128211954
Total Pages : 410 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Modeling and Control of Drug Delivery Systems by : Ahmad Taher Azar

Download or read book Modeling and Control of Drug Delivery Systems written by Ahmad Taher Azar and published by Academic Press. This book was released on 2021-02-06 with total page 410 pages. Available in PDF, EPUB and Kindle. Book excerpt: Modeling and Control of Drug Delivery Systems provides comprehensive coverage of various drug delivery and targeting systems and their state-of-the-art related works, ranging from theory to real-world deployment and future perspectives. Various drug delivery and targeting systems have been developed to minimize drug degradation and adverse effect and increase drug bioavailability. Site-specific drug delivery may be either an active and/or passive process. Improving delivery techniques that minimize toxicity and increase efficacy offer significant potential benefits to patients and open up new markets for pharmaceutical companies. This book will attract many researchers working in DDS field as it provides an essential source of information for pharmaceutical scientists and pharmacologists working in academia as well as in the industry. In addition, it has useful information for pharmaceutical physicians and scientists in many disciplines involved in developing DDS, such as chemical engineering, biomedical engineering, protein engineering, gene therapy. Presents some of the latest innovations of approaches to DDS from dynamic controlled drug delivery, modeling, system analysis, optimization, control and monitoring Provides a unique, recent and comprehensive reference on DDS with the focus on cutting-edge technologies and the latest research trends in the area Covers the most recent works, in particular, the challenging areas related to modeling and control techniques applied to DDS

Pain Management and the Opioid Epidemic

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309459575
Total Pages : 483 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Pain Management and the Opioid Epidemic by : National Academies of Sciences, Engineering, and Medicine

Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Drug Delivery

Author : Anya M Hillery
Publisher : CRC Press
ISBN 13 : 1482217740
Total Pages : 634 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Drug Delivery by : Anya M Hillery

Download or read book Drug Delivery written by Anya M Hillery and published by CRC Press. This book was released on 2016-09-15 with total page 634 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive introduction to advanced drug delivery and targeting, covering their principles, current applications, and potential future developments. This edition has been updated to reflect significant trends and cutting-edge advances that have occurred since the first edition was published. All the original chapters have been retained, but the material therein has been updated. Eight new chapters have been added that deal with entirely new technologies and approaches. Features: Offers a comprehensive introduction to the fundamental concepts and underlying scientific principles of drug delivery and targeting Presents an in-depth analysis of the opportunities and obstacles afforded by the application of nanotechnologies for drug delivery and targeting Includes a revised and expanded section on the major epithelial routes of drug delivery currently under investigation Describes the most recent, emerging, and innovative technologies of drug delivery Provides real-life examples of the clinical translation of drug delivery technologies through the use of case studies Discusses the pertinent regulatory hurdles and safety issues of drug delivery and targeting systems—crucial considerations in order to achieve licensing approval for these new technologies

Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems

Author : Ashok Katdare
Publisher : CRC Press
ISBN 13 : 1420004131
Total Pages : 474 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems by : Ashok Katdare

Download or read book Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems written by Ashok Katdare and published by CRC Press. This book was released on 2006-07-28 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new, yet to be developed, and approved excipients continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge potential new avenues for regulatory approval. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics.

Novel Drug Delivery Technologies

Author : Ambikanandan Misra
Publisher : Springer Nature
ISBN 13 : 9811336423
Total Pages : 448 pages
Book Rating : 4.8/5 (113 download)

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Book Synopsis Novel Drug Delivery Technologies by : Ambikanandan Misra

Download or read book Novel Drug Delivery Technologies written by Ambikanandan Misra and published by Springer Nature. This book was released on 2020-02-12 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: The application of drug delivery is a valuable, cost-effective lifecycle management resource. By endowing drugs with new and innovative therapeutic benefits, drug delivery systems extend products’ profitable lifecycle, giving pharmaceutical companies competitive and financial advantages, and providing patients with improved medications. Formulation development is now being used to create new dosage forms for existing products, which not only reduces the time and expense involved in new drug development, but also helps with regard to patent protection and bypassing existing patents. Today’s culture demands convenience, a major factor determining adherence to drug therapy. Over the past few years, patient convenience-oriented research in the field of drug delivery has yielded a range of innovative drug-delivery options. As a result, various drug-delivery systems, including medicated chewing gums, oral dispersible tablets, medicated lozenges and lollipops, have now hit the market and are very popular. These dosage forms offer a highly convenient way to dose medications, not only for special population groups with swallowing difficulties, such as children and the elderly, but for the general populace as well. This book provides valuable insights into a number of formulation design approaches that are currently being used, or could be used, to provide new benefits from existing drug molecules.

3D Printing of Pharmaceutical and Drug Delivery Devices

Author : Dimitrios A. Lamprou
Publisher : John Wiley & Sons
ISBN 13 : 1119835984
Total Pages : 276 pages
Book Rating : 4.1/5 (198 download)

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Book Synopsis 3D Printing of Pharmaceutical and Drug Delivery Devices by : Dimitrios A. Lamprou

Download or read book 3D Printing of Pharmaceutical and Drug Delivery Devices written by Dimitrios A. Lamprou and published by John Wiley & Sons. This book was released on 2024-05-15 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: 3D Printing of Pharmaceutical and Drug Delivery Devices 3D Printing of Pharmaceutical and Drug Delivery Devices Discover the latest, fast-developing technology to help move towards more cost-effective, small-batch, decentralized manufacturing of personalized systems 3D printing has revolutionized manufacturing. Its precision and flexibility have enabled the large-scale production of materials and devices too complex for conventional industrial manufacturing. This has been particularly revolutionary in the field of pharmaceutical production, where 3D printing is being integrated into the manufacture of both drugs and drug delivery devices. It has never been more important for industry professionals to understand this form of production. 3D Printing of Pharmaceuticals and Drug Delivery Devices: Progress from Bench to Bedside offers a comprehensive overview of 3D printing technology and its pharmaceutical applications. It introduces readers to a world in which bespoke drug delivery systems developed for specific users or conditions is rapidly becoming a reality. Its detailed coverage of strategies and industrial processes incorporates the latest research and real-world experience of production. 3D Printing of Pharmaceuticals and Drug Delivery Devices: Progress from Bench to Bedside readers will also find: A multi-disciplinary authorial team of industry leaders Discussion of common technical and regulatory barriers and their possible solutions Far-ranging discussion of pharmaceutical applications across all sectors 3D Printing of Pharmaceuticals and Drug Delivery Devices: Progress from Bench to Bedside is essential reading for pharmaceutical industry professionals and researchers looking to occupy the leading edge.

Fundamentals and Applications of Controlled Release Drug Delivery

Author : Juergen Siepmann
Publisher : Springer Science & Business Media
ISBN 13 : 1461408814
Total Pages : 593 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Fundamentals and Applications of Controlled Release Drug Delivery by : Juergen Siepmann

Download or read book Fundamentals and Applications of Controlled Release Drug Delivery written by Juergen Siepmann and published by Springer Science & Business Media. This book was released on 2011-12-15 with total page 593 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book approaches the subject from a mechanistic perspective that pitches the language at a level that is understandable to those entering the field and who are not familiar with its common phrases or complex terms. It provides a simple encapsulation of concepts and expands on them. In each chapter the basic concept is explained as simply and clearly as possible without a great deal of detail, then in subsequent sections additional material, exceptions to the general rule, examples, etc., is introduced and built up. Such material was generously supplemented with diagrams; conceptually elegant line diagrams in two or three colors. The artwork was well thought out and able to condense the scientific principles into a novel and visually exciting form. The diagrams encourage browsing or draw the reader to salient points. In addition, the technique of highlighting key concepts in a separate box is used throughout each chapter.

Medical Devices and the Public's Health

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309212456
Total Pages : 318 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine

Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.