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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final guidance Tuesday for outsourcing facilities on compounding and repackaging radiopharmaceuticals, along with draft guidance on insanitary conditions at compounding facilities.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
Genentech and Boehringer Ingelheim want the FDA to amend or clarify parts of its draft guidance on the use of liquids or soft foods as drug administration vehicles. Read More
In the latest development in the ongoing saga over Allergan’s transfer of Restasis patents to a Native American tribe, the partners sued Amneal for infringing upon two patents for the dry-eye drug. Read More
The Congressional Budget Office (CBO) estimates bipartisan legislation designed to speed generic drugs to market could save the federal government as much as $3.3 billion. Read More
FDA guidance on submitting field alert reports contradicts federal regulations on the time frame for when reports must be submitted, Perrigo and GlaxoSmithKline said in public comments. Read More