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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
House and Senate conferees reached agreement late Tuesday on a final version of an expansive legislative package to address the opioid crisis. Read More
Alkeus Pharmaceuticals will receive $1.75 million over four years for a phase II study of an experimental drug treatment for Stargardt disease. Read More
A survey found that over half of marketing authorization holders with “an important step in their regulatory processes in the UK” were on track to ensure that their authorizations remain valid post-Brexit. Read More
Endo argued that the FDA’s handling of bulk compounding laws violated the Drug Quality and Security Act when it treated the legislation as non-binding guidance instead of as a legal mandate. Read More