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In its latest study of direct-to-consumer ads, the FDA wants to know if the inclusion of efficacy information in drug advertisements affects how patients perceive the drug. Read More
The FDA is calling for increased focus on the underlying biology of diseases like Alzheimer’s and diabetes, noting that the discovery of biomarkers has led to important breakthroughs for cancer and HIV/AIDS. Read More
In a document released Friday, the Senate Appropriations Committee calls for fiscal year 2016 user fee amounts totaling nearly $1.2 billion for drugs and biologics — figures that are in line with those proposed by its counterpart in the House. Read More
Excipient makers preparing for the new GMP standard NSF/IPEC/ANSI 363 should be aware they are expected to police themselves to determine if they are meeting manufacturing requirements for their products. Read More
In a bipartisan 28-2 vote, the Senate Appropriations Committee Thursday approved the fiscal year 2016 appropriations bill to fund the FDA, but at levels far below what President Barack Obama had requested. Read More
Companies developing therapies that may have an adverse effect on the testes should conduct clinical trials to pin down the toxicity and whether it is reversible, the FDA says. Read More
As lawmakers work to draft a Senate version of the 21st Century Cures Act, indications are that it will be much smaller than the massive FDA overhaul bill passed by the House, with reforms focused on just a handful of issues. Read More