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The FDA is proposing revisions to an adverse events reporting form that includes, for the first time, a section for large compounders to submit events. Read More
The FDA wants manufacturers to stop sending paper prescribing information to pharmacists and physicians who often don’t read it and only submit it electronically to the agency, a move that would create a single source for accurate labeling that would always be up to date. Read More
A recent FDA inspection of contract research organization GVK Biosciences’ Hyderabad, India, plant turned up no evidence of safety or efficacy concerns with U.S.-bound generic therapies, a finding that is in sharp contrast to initial conclusions reached by European inspectors. Read More
A recent FDA inspection of contract research organization GVK Biosciences’ Hyderabad, India, plant turned up no evidence of safety or efficacy concerns with US-bound generic therapies, a finding that is in sharp contrast to initial conclusions reached by European inspectors. Read More
German regulators have published a list of 80 generic medicines whose approvals were yanked after EU authorities expressed concerns with contract research organization GVK Biosciences. Read More
The FDA is proposing revisions to an adverse events reporting form that includes for the first time a section for large compounders to submit events. Read More