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The 510(k) Premarket Notification is the primary FDA submission pathway for most Class II medical devices. It demonstrates that a new device is substantially equivalent to a legally marketed predicate device. Proper preparation, documentation, and FDA interaction are critical for timely clearance and market access in the United States. At [...]
The US FDA Drug Establishment Registration is a mandatory requirement under 21 CFR Part 207 for all facilities engaged in the manufacturing, repacking, relabeling, or distribution of human and veterinary drugs intended for the U.S. market. This regulation applies to both domestic and foreign facilities, ensuring that all establishments involved [...]
In the highly regulated pharmaceutical and healthcare industry, compliance with the U.S. Food and Drug Administration (FDA) is not optional it is a business necessity. When drug products are found to be misbranded, adulterated, or unsafe, the FDA may require a recall or initiate enforcement actions. Mishandling a recall can [...]
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. [...]
Over-the-counter (OTC) drugs play a vital role in the U.S. healthcare market, allowing consumers to access safe and effective treatments without a prescription. To ensure public safety, the U.S. Food and Drug Administration (FDA) regulates OTC products under the OTC Drug Monograph system. Compliance with these monographs is mandatory for [...]
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 [...]
For FDA-regulated industries such as food, cosmetics, dietary supplements, and pharmaceuticals, preparing for an FDA inspection is essential to ensure uninterrupted market access. Inspections are designed to verify compliance with U.S. Food and Drug Administration (FDA) regulations, including cGMP (Current Good Manufacturing Practice), labeling requirements, and safety standards. Companies that [...]
The US FDA Drug Listing process is a mandatory compliance requirement for all human and veterinary drug products marketed in the United States. Under 21 CFR Part 207, every registered drug establishment must submit detailed information about each drug product they manufacture, repack, relabel, or distribute. This process ensures the [...]
Accurate and compliant drug labeling is one of the most critical requirements for marketing human and veterinary drugs in the United States. Under 21 CFR Part 201, the U.S. Food and Drug Administration (FDA) sets forth detailed labeling rules to ensure that healthcare providers and consumers have access to safe, [...]
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 [...]