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Food and Drug Administration (FDA) › Pharmaceutical Industry › Standard Operating Procedures

Gardner Law

FDA Issues Numerous Warning Letters

Gardner Law on

The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

Ankura

Pharma Companies Can Ensure Data Integrity With User Access Management (UAM)

Ankura on

Life sciences industry has regulatory compliance at the center of all its operations, so maintaining the integrity of data has always been a pressing need for this industry globally. Regulators such as the United States Food...more

Oberheiden P.C.

FDA Inspection Audit? What to Expect

Oberheiden P.C. on

The Food and Drug Administration is the federal agency charged with ensuring the safety of food, medication and other consumable products. In carrying out its duties, the FDA conducts both inspections of plants and...more

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