With an increase in self-medication, the demand to have drug labels provide as much information as possible is growing. In the pharmaceutical industry, customers and patients must be protected by a clear, concise label that provides information about medications. Drug labels must provide customers with a way to know more about their formulas, how they are used, and what to do if there is a medical emergency. There shall be written procedures designed to ensure proper labeling, markings, and packing materials are used for the drugs products, and those written procedures shall be followed.
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This article talks about the FDA guidance on regulatory submission of Real World Data(RWD) and Real World Evidence(RWE) for the evaluation of a drug product safety and efficacy.