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The U.S. Supreme Court on Friday weighed in on the debate over access to the abortion pill mifepristone, permitting a stay sought by the Department of Justice earlier this month and adding a layer of complexity to an already tangled tale of drug approval and access. Read More
The FDA Office of Prescription Drug Promotion (OPDP) is seeking input on its proposal to conduct research into how consumers interpret certain quantitative information about prescription drugs often included in direct-to-consumer (DTC) advertising. Read More
The European Medicines Agency (EMA) has become the first regulator to accept the International Council for Harmonization (ICH) S12 guideline, laying out the council’s recommendations for how to conduct nonclinical biodistribution (BD) studies when developing gene therapy products. Read More
GenBioPro, the only U.S. maker of the generic version of the abortion pill mifepristone, has sued the FDA, HHS and DOJ in an effort to protect the company from regulatory action that could withdraw or limit FDA approval of its drug based on recent court rulings. Read More
The FDA’s latest proposed trial design for evaluating the effectiveness of opioids as chronic pain treatments was met with backlash from pain management and anesthesiology experts who contend the protocol is flawed on multiple fronts. Read More
The FDA would like to have the regulatory authority to restrict new opioid approvals to those that are safer than already-approved and marketed opioids, Commissioner Robert Califf told senators at a hearing discussing the agency’s 2024 budget request. Read More
In a new interview posted to its website, top officials in the FDA’s Center for Drug Evaluation and Research (CDER) highlight key benefits of the Guidance Snapshot Pilot Program, which aims to make the agency’s often byzantine and highly technical guidance documents more accessible to a wide range of stakeholders. Read More
The top citations in FDA warning letters tend not to change radically from one year to the next, but the agency’s warning letters for fiscal 2022 hint at an increased focus on component testing and contractor oversight. Read More
Going back to pre-2016 restrictions around the abortion drug Mifeprex — which a federal appeals court now seeks to do — would set off a cascade of problems that could take months, if not longer, to work out and cause the drug to be misbranded in the meantime, according to FDA Principal Deputy Commissioner Janet Woodcock. Read More