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Small Business Guide to the Food and Drug Administration (FDA)

Small Business Guide to the Food and Drug Administration (FDA)
Author: U.s. Food and Drug Administration
Publisher: Fondo Editorial PUCP
Total Pages: 636
Release: 2014-09-04
Genre: Business & Economics
ISBN: 9789972425691

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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.


Generic and Innovator Drugs

Generic and Innovator Drugs
Author: Donald O. Beers
Publisher:
Total Pages: 0
Release: 1995
Genre: Drugs
ISBN:

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Winning at FDA

Winning at FDA
Author:
Publisher:
Total Pages: 40
Release: 1992
Genre: Drugs
ISBN: 9780914176435

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A Food Labeling Guide

A Food Labeling Guide
Author:
Publisher:
Total Pages: 72
Release: 1999
Genre: Food
ISBN:

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Drug and Biologic Approvals

Drug and Biologic Approvals
Author: Frank J. Sasinowski
Publisher: Fdli
Total Pages: 159
Release: 2000
Genre: Drug approval
ISBN: 9781885259684

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FDA Regulatory Affairs

FDA Regulatory Affairs
Author: Douglas J. Pisano
Publisher: CRC Press
Total Pages: 466
Release: 2008-08-11
Genre: Medical
ISBN: 1040061974

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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


Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Us Food and Drug Administration Regulation) (Fda) (2018 Edition)

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Us Food and Drug Administration Regulation) (Fda) (2018 Edition)
Author: The Law The Law Library
Publisher: Createspace Independent Publishing Platform
Total Pages: 412
Release: 2018-09-23
Genre:
ISBN: 9781727572667

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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