A Drug Master File (DMF) is a confidential, detailed submission to the U.S. Food and Drug Administration (FDA) that provides information about the facilities, processes, and materials used in the…
Compliance with controlled substances regulations is one of the most highly regulated areas in the U.S. pharmaceutical industry. Companies dealing with narcotics, psychotropics, or precursor chemicals must comply with both…
Launching a new drug in the United States requires rigorous compliance with FDA regulations, starting with the Investigational New Drug (IND) application. An IND is mandatory before beginning any clinical…
Compliance with Current Good Manufacturing Practices (cGMP) is mandatory for all pharmaceutical manufacturers, repackers, relabelers, and distributors who want to market drug products in the United States. Governed under 21…
For companies manufacturing, repacking, relabeling, or distributing human and veterinary drugs, annual and ongoing compliance with the U.S. Food and Drug Administration (FDA) is a mandatory responsibility. Non-compliance can lead…
To bring a generic drug to the U.S. market, sponsors must file an Abbreviated New Drug Application (ANDA) with the FDA. A key requirement of the ANDA process is proving…
Bringing a pharmaceutical product to the U.S. market requires rigorous regulatory approval by the U.S. Food and Drug Administration (FDA). For drug manufacturers, this process involves filing either an Abbreviated…
The Voluntary Cosmetic Registration Program (VCRP) is an FDA-operated electronic system designed for cosmetic product establishments and formulation listings in the United States. While registration under VCRP is not mandatory,…
For foreign cosmetic companies seeking access to the U.S. market, appointing a U.S. Agent is not optional it is a mandatory requirement under FDA regulations. Any cosmetic facility located outside…
In the highly regulated U.S. cosmetics market, even established brands may face situations where products must be withdrawn due to safety concerns, misbranding, or contamination. Under the Modernization of Cosmetics…