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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
CDER’s Office of New Drugs (OND) Director Peter Stein is a nationally recognized leader in pharmaceutical research and development. Before joining the FDA in 2016 as OND deputy director he was a vice president at Merck Research Laboratories and formerly a vice president at Janssen. Read More
The White House said Thursday that it will ask the U.S. Supreme Court to step in to defend the FDA’s 22-year-old decision to approve the abortion drug mifepristone after an appeals court denied the Justice Department’s request to allow full access to the drug on Wednesday. Read More
Bluebird Bio’s lovotibeglogene autotemcel (lovo-cel) and Vertex Pharmaceuticals’ exagamglogene autotemcel (exa-cel) gene therapies for severe sickle cell disease (SCD) would probably be cost-effective if priced around $2 million, according to a draft review by the Institute for Clinical Evaluation and Research (ICER). Read More
Arbutus Biopharma — which has been going after makers of the two messenger RNA (mRNA)-based COVID-19 vaccine makers alleging patent infringement — suffered a loss this week when a U.S. appeals court affirmed a decision to cancel its patent related to Moderna’s vaccine. Read More
Multiple devices and digital behavioral interventions have been approved or are in the works to help patients suffering from opioid use disorder (OUD), says FDA Commissioner Robert Califf, but obstacles such as a high failure rate and proof of efficacy stand in the way of wider adoption. Read More
The drug candidate is being evaluated in a phase 1 study in patients with advanced metastatic or progressive solid tumors who are either resistant to or can’t tolerate the standard therapy. Read More