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The European Medicines Agency (EMA) reported “remarkable” progress despite the pandemic in a mid-point assessment of its “Regulatory Science Strategy to 2025” to build a more adaptive regulatory system that will encourage innovation — including advances in clinical trials and a new real-world data (RWD) network. Read More
The FDA announced yesterday that its generic drug program has resumed in-person, face-to-face meetings with industry, in a phased-in approach alongside videoconference meetings. Read More
A California judge has ruled that a lawsuit by one individual against GlaxoSmithKline (GSK) for its heartburn drug, Zantac (ranitidine), may go ahead — potentially setting the stage for other Zantac consumers in the state to have their day in court. Read More
The pandemic has exposed longstanding vulnerabilities in the U.S. medical supply chain as well an overreliance on China and other countries, according to a new report on drug shortages by the majority staff on the Senate Committee on Homeland Security and Governmental Affairs. Read More
Private group or individual health plans would be required to cover one of each insulin dosage form (a vial or pen) and insulin type (rapid-acting, short-acting, intermediate-acting and long-acting) for no more than $35 per month. Read More
The Biden administration’s fiscal 2024 budget request dedicates a total of $59 million for new efforts to increase drug and device supply chain security, HHS Secretary Xavier Becerra told Congress last week. Read More
The International Council for Harmonization (ICH) has finalized a new guideline covering nonclinical considerations for gene therapies, setting the stage for individual ICH member nations to accept and release their own versions of the guideline. Read More
Sponsors of new oncology drugs and biologics that aim to apply for Accelerated Approval (AA) should use a randomized controlled trial (RCT) design rather than a single-arm trial in most cases, the FDA advises in new draft guidance issued last week. Read More
The company also relied on suppliers’ certificates of analysis for incoming components “without establishing the reliability of [the] suppliers’ test results,” the agency said. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has proposed major reforms to its clinical trial regulations — including a 30-day maximum for reviewing new trial applications and a 10-day maximum for granting a decision after receiving requested follow-up information. Read More
The Federal Trade Commission (FTC) has filed an amicus brief urging the U.S. District Court for the District of Delaware not to dismiss the suit brought by Sage Chemical and its marketing partner TruPharma against Supernus Pharmaceuticals over alleged blocking of generic competition. Read More