Draft LASIK Guidance: Why Did FDA Issue New Labeling Recommendations for Products that Already Have PMA Approved Labeling?
FDA Law Blog
DECEMBER 12, 2022
intrusion [into] the doctor-patient relationship. FDA has already approved the patient labeling in connection with each individual manufacturer’s PMA approval. While there are PMA supplements steadily filed in this product code until the present, it appears from FDA’s database that the last original PMA approval was in 2006.
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