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Pharmaceutical companies must ensure the safety and effectiveness of their products even after FDA approval and U.S. market entry. This ongoing responsibility is managed through post-market reporting and pharmacovigilance programs, which play a critical role in identifying, assessing, and mitigating potential risks associated with human and veterinary drugs. The U.S. [...]
Importing Active Pharmaceutical Ingredients (APIs) and finished drug products into the United States requires strict compliance with U.S. Food and Drug Administration (FDA) and U.S. Customs & Border Protection (CBP) regulations. Any gaps in registration, labeling, or documentation can result in detention, refusal, or costly delays at U.S. ports of [...]
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 [...]