AnFDA guidance, as the title suggests, is a set of suggestions from the FDA on a number of its governing areas. The FDA, being a regulatory body sets standards for almost every conceivable area. It is almost impossible to list the number of guidances the FDA has issued.
Nonbinding in nature
Guidances are suggestions for best practices and methods, and are not a set of rules. The outstanding characteristic of FDA guidances is that they are nonbinding. The FDA website states as much: “This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.”
This note is to be found in guidances the FDA issues in every of its governing areas. As can be seen from the above explanation; guidances are open to interpretation, and the individual, group of individuals, organizations or laboratories that come under these guidances are free to offer their own perspective. They can discuss industry-specific guidances with the FDA and sort out matters whenever disagreements arise.
General areas for FDA guidance
These are the broad areas in which the FDA has issued guidances:
- Medical Devices
- Vaccines, Blood & Biologics
- Animal & Veterinary Cosmetics
- Radiation-Emitting Products
- Tobacco Products
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