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What is the full form of IOM in pharma?

The Investigations Operations Manual (IOM) is the primary operational reference for FDA investigators and other field employees to perform investigational activities in support of the agencys public health mission.

How do I report an allergic reaction to the FDA?

Consumers and health professionals can file a report online with MedWatch. You also can call the FDA Division of Drug Information at 301-827-4573.

How do you report any problems with a drug or adverse reactions to the FDA?

Call 1-800-FDA-1088 to report by telephone. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (Send only page 1 plus any continuation pages - do not send instruction pages).

What is the FDA definition of an investigation?

The FDA defines a clinical investigation as any experiment that involves a test article and one or more human subjects, when the test article is or would be FDA-regulated.

What should be reported to the FDA?

Consumers can play an important public health role by reporting to FDA any adverse reactions or other problems with products the agency regulates. FDA is responsible for ensuring that foods are safe, wholesome, and correctly labeled.

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