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The FDA offers recommendations for using electronic systems, records and signatures in clinical trials, including advice on validation, in a draft guidance released Wednesday. Read More
Sponsors developing long-acting local postoperative anesthetics should consider including novel, clinically meaningful endpoints in their trial design, the FDA has said in new draft guidance. Read More
On Wednesday, the Biden administration released a list of 27 drugs and biologics whose prices are rising faster than the rate of the inflation, and thus whose manufacturers will owe a hefty fine to the Medicare Trust Fund in 2025. Read More
The Alliance to Save America’s 340B Program (ASAP) — a coalition of industry stakeholders, community health centers and provider and consumer advocates — has called for reforms of the drug discount program for hospitals that treat low-income patients.
Novo Nordisk will cut the U.S. list price of multiple insulin products by up to 75 percent, following rival Eli Lilly’s announcement of a similar price cut earlier this month.
The Biden administration has asked Congress for almost $200 million in additional FDA funding for fiscal 2024 to enhance medical product safety and an extra $105.3 million to fully fund increases in the agency’s employee pay.
Formology Lab of Chatsworth, Calif., earned an FDA warning letter for failing to verify the identity of each component of a drug product, having no written procedures for process or production control as well as not having established an adequate quality control unit, among other serious lapses.
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