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The European Medicines Agency (EMA) is updating its Priority Medicines (PRIME) program to include new ways to track a product’s progress toward approval and to get more timely advice from the agency. Read More
Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER), explained her center’s top budget priorities for fiscal 2024 — highlighting steps to shore up the drug supply chain and improve generics availability — yesterday at an Alliance for a Stronger FDA webinar. Read More
In a move to help prevent or mitigate shortages, the FDA is asking drugmakers to provide more information regarding manufacturing disruptions that could affect finished drugs and biological products as well as some active pharmaceutical ingredients (API). Read More
AdvaMed has submitted an amicus brief to the U.S. Supreme Court in support of two supermarket chains accused of violating the False Claims Act by misreporting their drug prices, arguing that the errors were due to complex and sometimes conflicting regulations. Read More
In its latest move to address the opioid overdose crisis, the FDA is requiring opioid manufacturers to provide prepaid mail-back envelopes to outpatient pharmacies and other dispensers to make it easier for patients to dispose of unused opioids. Read More
FDAnews welcomes to its new editorial advisory board seven thought leaders with deep experience in the drug, device and clinical research industries. These seven experts are at the top of their field and will help provide our readers with even greater depth and analysis of drug and device industry news and trends. Read More
Since the FDA knew the end of the public health emergency was nigh, the agency already had begun working with holders of EUAs to transition them to full approval, Marks said.
An appeals court ruled that Teva “induced infringement” of GSK’s patent by pressing doctors to prescribe its generic version of a cardiac medicine rather than GSK’s brand-name congestive heart failure drug. Read More
The company filed a Freedom of Information Act (FOIA) request asking the FDA to release all of the documents pertaining to its no-go decision. Read More
A federal jury has ordered Novartis’ Sandoz subsidiary to pay $39 million in damages to Allergan and Duke University for infringement of patent rights for Allergan’s eyelash-enhancing therapy Latisse (bimatoprost). Read More