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A sweeping deal to keep the government running through next fall is expected to come to a vote Friday, under which the FDA would be awarded $4.68 billion in total funding for fiscal year 2016. Read More
The FDA is recommending that drugmakers create safety assessment committees and formalized surveillance plans to watch for serious adverse events in clinical trials to decide when safety data should be unblinded. Read More
Eli Lilly scored a win at the FDA Wednesday, with the agency approving the company’s insulin glargine injection, Basaglar, to improve glycemic control in patients with Type 1 and 2 diabetes. Read More
The House Energy & Commerce Committee is calling on the GAO to evaluate whether the FDA’s regulatory pathway for generic versions of complex drugs is sufficient. Read More
With the clock about to strike midnight on 2015, CDER Director Janet Woodcock laid out a set of priorities the center will focus on in 2016, with negotiating new PDUFA and GDUFA agreements topping that list. Read More
India’s Central Drugs Standard Control Organization has unveiled three new guidelines that it says paves the way forward for more clinical trials in the country by reducing red tape for clinical research. Read More
The head of the World Health Organization is speaking out against the Trans Pacific Partnership, contending that the 12-country deal could cause drug prices to spike. Read More
Two senators are pressing the Department of Health and Human Services to authorize prescription drug importation to combat price manipulation. Read More
To spur greater mutual inspection reliance between the FDA and EU, the agency and Congress are working to grant the EMA access to unredacted inspection reports. Read More