What is U.S FDA ?
The Food and Drug Administration (FDA or USFDA) is a federal agency which is the part of the United States Department of Health and Human Services. It is one of the United States federal executive departments.
The FDA evaluates and approves many different things, including:
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The FDA exercises authority for inspections of facilities in foreign countries which supply pharma and food products to the US. So, pharma and food plants in India that export to the US must adhere to the CGMP (current good manufacturing practices) as per FDA guidelines. FDA officials visit the facilities to check compliance with the rules.
FDA issues Form 483 at the completion of inspection. If it finds deviations from CGMP, it is mentioned in the Form 483. The form specifies areas in which the facility fell short of regulatory expectations. It is then presented and discussed with the management of the company. Along with the Form 483, the FDA also issues an Establishment Inspection Report (EIR) which specifies whether action is required to be taken.
The FDA calls for a response to the Form 483 observations within 15 working days. Though a written response is not mandatory, it is preferred so that a warning letter can be avoided. The company has to respond to the observations in detail with reasons for the shortcomings and corrective action plans. Each observation should be addressed individually.
If the management does not convincingly address the Form 483 observations within the specified time period, the FDA issues a warning letter. Sometimes, if the observations are of a severe nature, the FDA may issue a warning letter even without issuing Form 483. Unsatisfactory response to the warning letter could lead to further action including import alert for products or the facility, withholding of product approval, and suspension or cancellation of manufacturing license.
In order to receive FDA approval for a drug or a high-risk medical device, a drug’s or device’s manufacturer must prove to the FDA that the item is “safe and effective.” Although no drug or medical device is entirely risk-free, the research and testing must show that the benefits of the drug or device for a particular condition outweigh the risks to patients of using the item.
The FDA does not do its own testing of new drugs, medical devices, or other items. Instead, it reviews the results of clinical testing and studies performed by the item’s manufacturer. The FDA approval process requires the manufacturer to work with the FDA during human trials of drugs and other devices to ensure trials meet rigorous scientific standards and that human subjects are protected from unnecessary risks. The FDA uses its own statisticians, biologists, chemists, physicians, and other experts to analyze the data from the manufacturer’s clinical trials and other research. Based on this analysis, the agency decides whether or not to approve a drug or medical device for a particular use.
The USA is the major market for several Indian pharma companies. In the not-too-distant past, many Indian pharma companies grew strongly because of high exports to the US. In fact, Indian companies have become dominant players in the US generic drugs space. Many pharma companies in the country have made major investments in facilities with the hope of continuing export growth to the US
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Our associates have years of experience as industry experts responsible for international Quality System Regulation/ current Good Manufacturing Practice (QSR/cGMP) inspections of pharmaceutical and medical device manufacturers, Biomedical Monitoring / Good Clinical Practice (BIMO/GCP) and Good Laboratory Practice (GLP) audits.
FDA (U.S. Food and Drug Administration)
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