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The compromise measure includes a provision from the Senate bill requiring prescription opioids to be packaged in three- or seven-day blister packs. Read More
The agency will not take action against facilities that compound a radiopharmaceutical that is essentially a copy of an approved drug with “minor deviations.” Read More
One bill would ban the practice specifically for individual-market plans and employer sponsored group plans, while the other would prohibit it for Medicare Part D or Medicare Advantage plans. Read More
The FDA’s final guidance on non-proprietary naming for biologics directs both reference products and biosimilars to share the same core name, with both products bearing a different four-letter suffix. Read More
The complaint alleges AstraZeneca deployed nurses to illegally recommend three drugs to doctors and patients under the guise of offering expert advice. Read More
Mylan and Novartis criticized the FDA’s use of arbitrary suffixes in a non-proprietary naming convention for biologics in comments about a Sept. 4 a public hearing aimed at promoting biosimilars and interchangeable products. Read More
The company responded to the Form 483 observations on Aug. 24 and provided more information in the following weeks to address the agency’s concerns. Read More
The agency said drug shortages have become an increasing problem in Australia, as the current voluntary scheme for reporting shortages has proven ineffective. Read More