FDA report on enforcement and compliance PDF Download

Author:
Publisher:
ISBN:
Category :
Languages : en
Pages :

View

Book Description

Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Drug adulteration
Languages : en
Pages : 144

View

Book Description

Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Drug adulteration
Languages : en
Pages : 474

View

Book Description

Author: Food and Drug Administration
Publisher:
ISBN: 9780865879737
Category : Drugs
Languages : en
Pages : 0

View

Book Description
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.

Author: Howard L. Dorfman
Publisher:
ISBN: 9781402438486
Category : Drugs
Languages : en
Pages :

View

Book Description

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212456
Category : Medical
Languages : en
Pages : 318

View

Book Description
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.

Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Drug adulteration
Languages : en
Pages : 140

View

Book Description

Author:
Publisher:
ISBN:
Category : Drug adulteration
Languages : en
Pages : 12

View

Book Description

Author: United States. Food and Drug Administration. Division of Microbiology
Publisher:
ISBN:
Category : Microbiology
Languages : en
Pages : 180

View

Book Description

Author: United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher:
ISBN:
Category : Advertising
Languages : en
Pages : 32

View

Book Description