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Regulatory Agency Reporting

Regulatory Agency Reporting Once a pharmaceutical product is introduced into commercial distribution, a number of changes or events can trig...

Enforcement Actions

Enforcement Actions Pharmaceutical companies and the regulatory agencies that provide oversight for their activities share a responsibility ...

Regulatory Inspections

Regulatory Inspections INSPECTION AUTHORITY The Food, Drug, and Cosmetic Act (FDCA) grants the United States Food and Drug Administration (F...

Mutual Recognition Agreements

Mutual Recognition Agreements MUTUAL RECOGNITION AGREEMENTS Mutual recognition agreements (MRA) are international agreements that specify th...

Regulations and Guidances

Regulations and Guidances It is necessary to possess the ability to interpret regulations and guidelines as published or administered by the...

Global Regulatory Framework

Global Regulatory Framework UNITED STATES FEDERAL STATUTES RELEVANT TO PHARMACEUTICALS The Administrative Procedure Act The Administrative P...

Labeling Operations and Controls

Labeling Operations and Controls Labels are an integral part of the drug product packaging process and the marketing of the final drug produ...

Packaging Operations and Controls

Packaging Operations and Controls One of the most important functions that the product packaging provides is the protection of its contents....