FDA Investigations Operations Manual
Title | FDA Investigations Operations Manual PDF eBook |
Author | Food and Drug Administration |
Publisher | |
Pages | 0 |
Release | 2003 |
Genre | Drugs |
ISBN | 9780865879737 |
Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.
FDA Investigations Operations Manual for Drugs, Devices, Biologics & Cosmetics
Title | FDA Investigations Operations Manual for Drugs, Devices, Biologics & Cosmetics PDF eBook |
Author | |
Publisher | Washington Business Information Incorporated |
Pages | 192 |
Release | 1993-01-01 |
Genre | Law |
ISBN | 9780914176503 |
FDA Biotechnology Inspection Guide
Title | FDA Biotechnology Inspection Guide PDF eBook |
Author | United States. Food and Drug Administration |
Publisher | |
Pages | 62 |
Release | 1991 |
Genre | Biotechnology |
ISBN |
Rare Diseases and Orphan Products
Title | Rare Diseases and Orphan Products PDF eBook |
Author | Institute of Medicine |
Publisher | National Academies Press |
Pages | 442 |
Release | 2011-04-03 |
Genre | Medical |
ISBN | 0309158060 |
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.
Medical Devices and the Public's Health
Title | Medical Devices and the Public's Health PDF eBook |
Author | Institute of Medicine |
Publisher | National Academies Press |
Pages | 318 |
Release | 2011-11-25 |
Genre | Medical |
ISBN | 0309212421 |
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.
Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease
Title | Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease PDF eBook |
Author | Institute of Medicine |
Publisher | National Academies Press |
Pages | 335 |
Release | 2010-06-25 |
Genre | Medical |
ISBN | 0309157277 |
Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.
Pain Management and the Opioid Epidemic
Title | Pain Management and the Opioid Epidemic PDF eBook |
Author | National Academies of Sciences, Engineering, and Medicine |
Publisher | National Academies Press |
Pages | 483 |
Release | 2017-09-28 |
Genre | Medical |
ISBN | 0309459575 |
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.