A Small Business Guide to FDA.
Author | : |
Publisher | : |
Total Pages | : 24 |
Release | : 1982 |
Genre | : Small business |
ISBN | : |
Download A Small Business Guide to FDA. Book in PDF, ePub and Kindle
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download A Small Business Guide To Fda PDF full book. Access full book title A Small Business Guide To Fda.
Author | : |
Publisher | : |
Total Pages | : 24 |
Release | : 1982 |
Genre | : Small business |
ISBN | : |
Author | : U.s. Food and Drug Administration |
Publisher | : Fondo Editorial PUCP |
Total Pages | : 636 |
Release | : 2014-09-04 |
Genre | : Business & Economics |
ISBN | : 9789972425691 |
The purpose of this guide is to help small businesses - usually those with fewer than 500 employees - successfully navigate the realm of regulatory measures with which he U.S. Food and Drug Administration (FDA or the Agency) protects and promotes the health of the American public.Familiarity with FDA requirements is very important for a small firm that manufactures or plans to manufacture, sell, warehouse, transport, or import any of the thousands of FDA regulated products. To reach the U.S. interstate market, these products must comply with the applicable laws and the science-based public health rules developed and enforced by FDA.Although this obligation is routinely fulfilled by hundreds of thousands of American businesses, FDA is aware that for a small firm it can present a challenge. The Agency's responsibilities are defined in some 200 federal laws, and the resulting requirements, which can be complex, cover hundreds of pages in the Code of Federal Regulations. To find their way in this extensive domain of requirements, small and start-up businesses are likely to need expert assistance.The purpose of this guide is to help satisfy this need. Chapters I-IV provide an overview of FDA's responsibilities and operations and outline the main areas where small firms are most likely to come in contact with the Agency. Chapter V provides links to information that small businesses most frequently request from FDA's product centers and the Agency's Office of Regulatory Affairs. Chapter VI lists the Agency's offices and individuals who are ready to help small firms resolve their regulatory problems.This guide is designed to help make the small firms' contacts with FDA as efficient and productive as possible. We present this document as a blueprint that firms can follow to achieve their business aims while helping FDA accomplish its public health mission.
Author | : |
Publisher | : |
Total Pages | : 17 |
Release | : 1982 |
Genre | : Small business |
ISBN | : |
Author | : Donald O. Beers |
Publisher | : |
Total Pages | : 0 |
Release | : 1995 |
Genre | : Drugs |
ISBN | : |
Author | : |
Publisher | : |
Total Pages | : 40 |
Release | : 1992 |
Genre | : Drugs |
ISBN | : 9780914176435 |
Author | : |
Publisher | : |
Total Pages | : 72 |
Release | : 1999 |
Genre | : Food |
ISBN | : |
Author | : Frank J. Sasinowski |
Publisher | : Fdli |
Total Pages | : 159 |
Release | : 2000 |
Genre | : Drug approval |
ISBN | : 9781885259684 |
Author | : |
Publisher | : |
Total Pages | : 0 |
Release | : 1997 |
Genre | : Medical instruments and apparatus |
ISBN | : |
Author | : Douglas J. Pisano |
Publisher | : CRC Press |
Total Pages | : 466 |
Release | : 2008-08-11 |
Genre | : Medical |
ISBN | : 1040061974 |
Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in
Author | : The Law The Law Library |
Publisher | : Createspace Independent Publishing Platform |
Total Pages | : 412 |
Release | : 2018-09-23 |
Genre | : |
ISBN | : 9781727572667 |
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA or we) is establishing science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA is establishing these standards as part of our implementation of the FDA Food Safety and Modernization Act. These standards do not apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance is eligible for exemption from the requirements of this rule. The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. We expect the rule to reduce foodborne illness associated with the consumption of contaminated produce. This book contains: - The complete text of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section