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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
Genentech has won full approval for its first-in-class combination therapy aimed at providing curative treatment for patients with previously untreated diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin lymphoma in the U.S. Read More
Before the passage of the Orphan Drug Act (ODA) in 1983, the logistical challenges and financial downsides of developing a drug for a very small population affected by a rare disease meant few drugs on the horizon. 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
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from medical device enforcement, real-world evidence and root cause analysis. Read More
Prolonged treatment time and maximum amyloid depletion appear key to slowing the cognitive decline of Alzheimer’s disease, researchers reported at the International Conference on Alzheimer’s & Parkinson’s Disease earlier this month. 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