Health Policy

Download Advancing Regulatory Science for Medical Countermeasure by Institute of Medicine, Board on Health Sciences Policy, PDF

By Institute of Medicine, Board on Health Sciences Policy, Forum on Medical and Public Health Preparedness for Catastrophic Events, Development, and Translation Forum on Drug Discovery, Anne B. Claiborne, Bruce M. Altevogt, Theresa Wizemann

Even if the us has secure and potent clinical countermeasures--such as vaccines, medicines, and diagnostic tools--available to be used in the course of a catastrophe can suggest the adaptation among lifestyles and dying for lots of american citizens. The nutrition and Drug management (FDA) and the medical neighborhood at huge may gain advantage from more desirable medical instruments and analytic options to adopt the advanced clinical evaluate and selection making had to make crucial clinical countermeasures on hand. on the request of FDA, the Institute of drugs (IOM) held a workshop to ascertain easy methods to enhance the advance, review, approval, and rules of clinical countermeasures.

During public overall healthiness emergencies equivalent to influenza or chemical, organic, radiological/nuclear (CBRN) assaults, secure and powerful vaccines, remedies, and different clinical countermeasures are necessary to preserving nationwide safeguard and the health of the general public. Advancing Regulatory technological know-how for clinical Countermeasure Development examines present clinical countermeasures, and investigates the way forward for study and improvement during this zone. Convened on March 29-30, 2011, this workshop pointed out regulatory technology instruments and techniques which are to be had or lower than improvement, in addition to significant gaps in presently to be had regulatory technological know-how instruments.

Advancing Regulatory technology for scientific Countermeasure Development is a important source for federal firms together with the nutrients and Drug management (FDA), the dept of wellbeing and fitness and Human prone (HHS), the dept of safety (DoD), in addition to overall healthiness execs, and private and non-private future health firms.

Show description

Read Online or Download Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary PDF

Similar health policy books

The Medical Delivery Business: Health Reform, Childbirth, and the Economic Order

American citizens on the finish of the 20th century fearful that controlled care had essentially reworked the nature of drugs. within the clinical supply enterprise, Barbara Bridgman Perkins makes use of examples drawn from maternal and toddler care to argue that the enterprise strategy in medication isn't really a brand new improvement.

Evidence-Based Medicine and the Changing Nature of Healthcare: 2007 IOM Annual Meeting Summary (Learning Healthcare Systems)

Drawing at the paintings of the Roundtable on Evidence-Based medication, the 2007 IOM Annual assembly assessed a few of the quickly taking place adjustments in healthiness care on the topic of new diagnostic and therapy instruments, rising genetic insights, the advancements in details expertise, and healthcare expenditures, and mentioned the necessity for a far better concentrate on proof to make sure that the promise of clinical discovery and technological innovation is successfully captured to supply the perfect deal with the appropriate sufferer on the correct time.

Health and Society in Britain since 1939 (New Studies in Economic and Social History)

British wellbeing and fitness coverage has passed through radical swap within the postwar interval and Virginia Berridge presents the following a concise and available survey of those alterations due to the fact 1939. whereas the increase, and up to date decline, of the NHS is tested intimately, this booklet additionally seems on the alterations within the function of medical professionals and linked clinical professions, and the new emphasis on "health advertising" and "primary care.

Review of the Fialuridine (FIAU) Clinical Trials (Fiau Clinical Trails)

In June 1993, a medical trial of fialuridine (FIAU), a promising new drugs for hepatitis B, was once without warning terminated while one of many 15 out-patients engaging within the nationwide Institutes of wellbeing and fitness (NIH) examine was once abruptly hospitalized with liver failure. even though, the entire final sufferers have been contacted and informed to prevent taking their drugs, six extra to that end built critical toxicity.

Additional info for Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary

Example text

These are high-risk, life-threatening diseases, about which clinical knowledge is often limited. Third, Leffel noted, there is a need for precompetitive mechanisms to share basic animal model information quickly. , for NIAIDsponsored studies, information on basic models for vaccine studies is available in cross-referenced master files for sponsors). Fourth, as noted by others, there must be ways to bridge nonclinical models to expected human outcomes, such as surrogate markers, correlates of protection, clinical observation in animals, and pathology.

He also noted that a DoD diagnostics leadership meeting held in October 2010 called for more inclusion in discussions and greater collaboration to develop diagnostics and to inform the regulatory roadmap for nextgeneration diagnostics. National Institute of Allergy and Infectious Diseases (NIAID) Michael Kurilla, of NIAID, explained that NIAID is taking a comprehensive approach to MCM development, with certain general criteria for vaccines, therapeutics, and diagnostics. By way of example, he noted that in the case of vaccines, it is important to consider alternatives for immunocompromised persons and special populations such as the elderly and children.

Rapid, real-time, step-in-step MCM development with regulatory oversight. This, Chu explained, would allow data collected during an emergency to be used later to validate test platforms. Copyright © National Academy of Sciences. All rights reserved. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary 26 ADVANCING REGULATORY SCIENCE FOR MCM DEVELOPMENT Validation methodology for assessing lot-to-lot differences of commercial products. • Allow for recognition of the diversity of diagnostic test producers.

Download PDF sample

Rated 4.09 of 5 – based on 17 votes