Small Business Guide to FDA

  • By: Staff Editor
  • Date: February 21, 2017
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Small Business Guide to FDA

FDA's regulations seek to prevent, or at the very least mitigate, health risks that slowly began to emerge over a century ago – with the industrialization of the production of food and pharma products. Over a period of time the Agency’s responsibilities came to be defined under about 200 federal laws.

While it becomes a challenge to stay updated with these complex laws, it is nevertheless mandatory for businesses that manufacture, sell, transport, warehouse, or import any FDA-regulated product.

This guide has been drafted to help small businesses – those with less than 500 employees — effectively navigate the multitude of regulatory measures that the U.S. Food and Drug Administration enforces to protect the health and welfare of the American public.

Related Training:

Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations

A Comprehensive View of FDA Regulations for Medical Devices

Contents of the Guide

The seven chapters within the guide will address several key areas of focus, such as: a broad overview of the Agency’s work and efforts; understanding FDA requirements; working with FDA; FDA inspections and product recalls; answers to small business FAQs; and general assistance and key contact details.

The guide will also discuss opportunities to engage in dialogues with the Agency through comments on rule proposals, FDA public meetings, hearings and conferences. This document serves as a blueprint for firms to follow and achieve their business aims while helping FDA accomplish its public health mission.

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