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President Barack Obama signed into law on Friday the fiscal 2016 omnibus spending bill, which contains $4.68 billion in total funding for the FDA. Read More
Turing Pharmaceuticals CEO Martin Shkreli has been indicted on seven counts of securities and wire fraud for alleged conduct at several of his previous companies. Read More
Drugmakers that have not started complying with worldwide track and trace regulations are behind the eight ball, as most companies only allow for two to three years for implementation, a supply chain expert warns. Read More
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