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The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, guidelines and GMP compliance. Read More
The FDA is advising generic drugmakers looking to revise their labels without the fallback of a reference product that they have only one route: supplemental submissions. Read More
The FDA is laying out compliance parameters for outsourcing facilities that compound near replicas of approved drugs, urging them not to distribute such products to patients that could use an approved drug. Read More
HHS Secretary Sylvia Burwell announced a final rule Tuesday that would more than double the number of patients for whom physicians can prescribe opioid rescue drugs. Read More