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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
The FDA issued final guidance Tuesday for outsourcing facilities on compounding and repackaging radiopharmaceuticals, along with draft guidance on insanitary conditions at compounding facilities. Read More
The EMA lowered its estimate for the number of centrally authorized drugs that may face post-Brexit supply disruptions from 108 to 39 — including 25 human medicines. Read More
Against a backdrop of declining sales for its branded hepatitis drugs, Gilead announced plans to launch its own “authorized generics” of two of its hep C treatments. Read More
The enforcement action “should send a clear message to the burgeoning iV therapy industry and sellers of all healthcare products,” said FTC Chairman Joe Simons. Read More