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FDA recently issued a revised draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and...
On January 18, 2024, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued its first untitled letter of the new year to Novartis...
On October 23, 2023, the Food and Drug Administration ("FDA") released a draft guidance for industry entitled "Communications From Firms to Health Care Providers Regarding...
Revised Draft FDA Guidance Expands Scope of Permissible Proactive Off-Label Communications This week, FDA published new revised draft guidance, Communications From Firms...
We pay tribute in this Bulletin to the late Robbie Robertson of The Band, who penned the 1968 classic, “The Weight,” and the harmonic lyric, “You put the load right on me.” The Food...