How to Use the FDA’s Final Guidance to Correctly Label Biosimilar Products
January 10, 2019 - Online Event ON CAWebinar Compliance
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The FDA has finalized its regulations on the content and format of labeling for prescription drug products, including biological products. The final labeling regulations, commonly known as the Physician Labeling Rule (PLR), help ensure that health care providers have clear and concise information in prescription drug labeling, and also make it easier for them to assess if the product is appropriate for use by their patient. If you’re developing draft labeling for biosimilar products for submission in a regulatory application, you need to know about the regulations so that you don’t run into any problems later.