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The Italian Medicines Agency has issued a noncompliance statement to Rome-based radiopharmaceutical maker Iason Italia, hitting the company over deficiencies primarily related to sterility assurance. Read More
A Los Angeles area supplement provider has been hit with an FDA warning letter for selling unapproved drugs for conditions ranging from kidney stones to stroke prevention. Read More
Dr. Reddy’s Laboratories has adopted a unique strategy to bypass legal issues surrounding its generic version of Nexium: changing the color of its capsules. Read More
In anticipation of proposed guidance on biosimilar interchangeability, AbbVie is requesting that the FDA hold a hearing to ensure the agency considers all viewpoints. Read More
Nearly a dozen organizations are calling for clarification on a draft FDA plan to label injectable therapies that are meant to be used multiple times by a single patient as products for “single patient–use.” Read More