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 scientific countermeasures--such as vaccines, medications, and diagnostic tools--available to be used in the course of a catastrophe can suggest the variation among lifestyles and demise for plenty of american citizens. The nutrition and Drug management (FDA) and the medical group at huge may gain advantage from more desirable clinical instruments and analytic innovations to adopt the advanced medical review and determination making had to make crucial scientific countermeasures to be had. on the request of FDA, the Institute of drugs (IOM) held a workshop to check how to increase the improvement, evaluate, approval, and law of scientific countermeasures.
During public healthiness emergencies reminiscent of influenza or chemical, organic, radiological/nuclear (CBRN) assaults, secure and powerful vaccines, remedies, and different scientific countermeasures are necessary to keeping 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 examine and improvement during this sector. Convened on March 29-30, 2011, this workshop pointed out regulatory technology instruments and techniques which are on hand or below improvement, in addition to significant gaps in presently to be had regulatory technological know-how instruments.
Advancing Regulatory technological know-how for clinical Countermeasure Development is a priceless source for federal companies together with the foodstuff and Drug management (FDA), the dep. of well-being and Human providers (HHS), the dept of safety (DoD), in addition to future health execs, and private and non-private wellbeing and fitness companies.
Read Online or Download Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary PDF
Similar health policy books
Governing medication discusses the idea and the perform of medical governance, and considers the theoretical, social and ancient heritage to discover assumptions in the back of it. It includes sections on scientific autonomy and governance, facts, technological know-how and drugs, and knowing scientific governance.
Even after Obama, America’s healthcare method continues to be damaged, and it’ll quickly bankrupt us all. the answer: radical simplification. Now, major healthcare specialist and entrepreneur Dr. Doug Perednia finds the system’s stunning, pointless inefficiencies--and outlines an easy, logical, whole resolution that provides larger protection, complements festival, and may retailer trillions.
The sufferer defense and cheap Care Act signed via President Obama in March 2010 is a landmark in U. S. social laws, and the excellent Court's fresh determination upholding the Act has ensured that it'll stay the legislations of the land. the recent legislations extends medical health insurance to just about all american citizens, gratifying a century-long quest and bringing the U.S. to parity with different business countries.
One of many nice myths of up to date American tradition is that the us’ nutrition offer is the most secure on the planet as the executive works to assure nutrients security and implement sure criteria on foodstuff manufacturers, processors, and vendors. actually U. S. foodstuff protection management and oversight have remained basically an analogous for greater than a century, with the natural nutrition and Drug Act and the Federal Meat Inspection Act of 1906 carrying on with to border nationwide coverage regardless of dramatic adjustments in creation, processing, and distribution in the course of the 20th century.
- The Management of Scientific Integrity within Academic Medical Centers
- Government and Public Health in America
- Infectious disease in aquaculture: Prevention and control
- Banking on the Body: The Market in Blood, Milk, and Sperm in Modern America
- Review of the DoD-GEIS Influenza Programs: Strengthening Global Surveillance and Response
Additional resources for Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary
NOTE: BLA, biologics license application; IND, investigational new drug application; NDA, new drug application. Figure 2-1 SOURCE: Susan McCune. 2011. Presentation at IOM workshop; Advancing Regulatory Science for Medical Countermeasure Development. Copyright © National Academy of Sciences. All rights reserved. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary MCM ENTERPRISE AND STAKEHOLDER PERSPECTIVES 17 Center for Biologics Evaluation and Research (CBER) Products regulated by CBER include blood, blood components and derivatives, vaccines, allergenic products, cell and gene therapies, xenotransplantation products, human tissues, and various related devices, explained Carolyn Wilson, associate director for research at CBER.
Biomarkers, animal models, correlates of protection). The most significant challenge, Lyons said, is the extrapolation of animal immunological and pathophysiological data to the human setting. What makes a good animal model is highly dependent on the research question, he said. One must consider, for example, whether there is similar pathophysiology as the human disease or similar mediators of immune protection. For product development, are there well-defined generic animal models or platforms that could be used?
While the DoD program has a sound science and technology base, Parker noted that the department lacks the ability to rapidly develop discoveries and manufacture new candidates against unknown threats. The DoD MCM Initiative strategy consists of two major elements, each with multiple initiatives: (1) science and technology (novel platform/expression systems for MCMs, regulatory science technologies, manufacturing technologies for biologics that support good laboratory practices [GLP]/good manufacturing practices [GMP]) and (2) advanced development (further maturation of novel platform/expression systems and integration into a production process; innovative, flexible, and agile manufacturing capabilities).