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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 manufacturing, processing, packaging, and storing of human drugs. While not legally required, DMFs are critical for companies that want to [...]
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 the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA). Overlapping requirements make compliance complex, requiring detailed [...]
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 trials involving human subjects. It ensures that the investigational product is safe for testing and that the study design meets [...]
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 CFR Parts 210 and 211, cGMP regulations establish the minimum requirements for methods, facilities, and controls used in the manufacturing, [...]
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 penalties, product recalls, import alerts, and loss of market access in the United States. XPRO America specializes in providing [...]
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 bioequivalence (BE) between the proposed generic and the reference listed drug (RLD). Bioequivalence demonstrates that the generic delivers the same [...]
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 New Drug Application (ANDA) for generic drugs or a New Drug Application (NDA) for novel, innovative drugs. The ANDA pathway [...]
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, it is strongly encouraged by the FDA as part of responsible industry practices. For manufacturers, packers, and distributors of cosmetic [...]
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 the United States that manufactures, packages, or processes cosmetic products for distribution in the U.S. must designate a U.S. Agent. [...]
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 Regulation Act (MoCRA), the FDA now has stronger authority to oversee recalls and enforce corrective actions. This makes it critical [...]