A recall is a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which it would initiate legal action (e.g., seizure). Recall Classification Recall Classification is the numerical designation, i.e., I, II, or III, assigned by the FDA to a…
FDA Adverse Event Reporting System (FAERS) monitors the safety of drugs & biologic products, contains reports of AE & medication errors that have been submitted to the FDA & to take appropriate action, such as updating drug labels/issuing safety communications. Bioequivalence (BE) Recommendations for Specific Products provides guidance on BE studies that helps applicants seeking…
The scope of FDA’s regulatory authority is very broad. FDA’s responsibilities are closely related to those of several other government agencies. The following is a list of traditionally recognized product categories that fall under FDA’s regulatory jurisdiction; however, this is not an exhaustive list.(including) Foods Drugs Biologics Medical Devices Cosmetics…
The FDA is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation. Company’s website or in commercial promoting a product or treatment some marketers may say their products are “FDA approved.” But how can you…
Put together an Inspection Team that will be responsible for dealing with the inspection when the FDA is on the premises. The inspection team should consist of: Responsible Person — Select a high-level officer or manager, someone with ultimate responsibility for the company’s compliance. This person could be as high level as the CEO…
If you are a manufacturer or a processor of FDA-regulated products, sooner or later, you can expect a visit from FDA. The purpose of this visit is to verify compliance with all relevant regulations — most commonly referred to as an “FDA inspection.” But not all inspections are created equal. FDA Inspections The four…
The drug approval process in the United States is overseen by the Food and Drug Administration (FDA), which ensures that drugs marketed in the country are safe and effective. Here are the general steps involved: 1. Preclinical Testing Before testing on humans, drugs undergo extensive laboratory and animal testing to assess their safety and…
The Abbreviated New Drug Application (ANDA) is a crucial regulatory pathway in the United States for the approval of generic drugs. This post provides a detailed overview of the ANDA process, its requirements, and significance in the pharmaceutical industry. 1. Purpose of ANDA ANDA allows pharmaceutical companies to demonstrate that their generic drug product…
