FDA Provides ANDA Sponsors with BE Study Recommendations for 42 Generic Drug Ingredients
January 29, 2016
On June 11, 2010, the FDA published its draft guidance entitled “Bioequivalence Recommendations for Specific Products.” This draft guidance “explained the process that would be used to make product-specific BE recommendations available to the public on FDA’s Web site.”
In addition, the Agency also released revised draft recommendations for the following 11 APIs:
Ciprofloxacin hydrochloride; hydrocortisone
FDA is seeking feedback from the public and will be accepting comments until March 28, 2016.
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