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FDA Calls for a Change in Drugs and Biologics Labeling

A new set of regulations from the Food and Drug Administration requires changes to the labeling of drugs and biologics if needed after the product earns regulatory approval. The main reason for the new labeling is to provide consumers with safety-related information discovered after the drug reaches the marketplace. It reflects the fact that while the efficacy of clinical trials remains fine, some problems are only detected when the product gets used by the general public.


Drug Manufacturers must Submit Post-Approval Incident Reports.

Current FDA regulations require drug manufacturers to submit incident reports after their product earns regulatory approval. If the incident in question was considered serious, life-threatening, or deadly, an expedited report must be turned into the FDA within 15 days. Other, not as serious, incidents get reported once a quarter for the first three years a drug is in the market, after which annual reporting takes place.

The new FDA regulations involve how these incidents get reported to the general public. In the past, when new safety information was discovered after a drug entered the marketplace, the FDA would negotiate with the manufacturer on a voluntary basis for an addendum to the label’s safety information. In some cases, the process could become protracted.


Safety Label Addendums must happen Quickly when Required.

Armed with these new regulations, the FDA can essentially demand a new safety label if they feel public safety warrants it. The manufacturer is then required to submit a label addendum to the FDA or run the risk of the government agency initiating enforcement actions which can include withdrawal of the product’s approval. Once a label change is approved by the FDA, it must appear on the manufacturer’s website within 15 days, and affixed to actual product soon after.


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