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No private vendors have stepped up so far to bid on Florida’s $30 million contract to devise a Canadian drug importation program aimed at lowering prescription drug prices in the state. Read More
The FDA unveiled a final guidance yesterday on referencing approved drug products in Abbreviated New Drug Application (ANDA) submissions that seeks to clear up confusion commenters expressed about draft guidance the agency issued Jan. 17, 2017. Read More
The FDA will not make COVID-19 vaccine developers go through pre-approval inspections for an Emergency Use Authorization (EUA), but companies will have to submit detailed manufacturing data and meet certain other requirements, said a senior official in the Center for Biologics Evaluation and Research (CBER). Read More
A study by the world body found no clinical benefit or improvement in survival outcomes for COVID-19 patients in a review of multiple trials. Read More
The FDA announced that a memorandum of understanding (MOU) between the agency and states for regulating traditional compounding pharmacies that distribute their products to other states is now available for signature by state health agencies. Read More
The FDA has had to push back its review of Spectrum Pharmaceuticals’ biologics license application (BLA) for Rolontis (eflapegrastim) due to COVID-19 travel restrictions. Read More
The UK’s Institute of Cancer Research said it is “deeply disappointed” by a decision by the National Institute of Health and Care Excellence (NICE) to recommend Merck’s Keytruda (pembrolizumab) as a first-line treatment for certain head and neck cancer patients but not in combination with chemotherapy. Read More
Walmart is suing the federal government seeking to block civil charges against the company over how it handled prescriptions for opioids that allegedly helped create the opioid epidemic. Read More
The FDA says it won’t take action against wholesale distributors that fail to verify a product identifier or standardized numerical label before distributing saleable returned products. Read More
The COVID-19 pandemic is worsening a pre-existing problem of drug shortages in the U.S., University of Minnesota researchers report in a new analysis. Read More
HHS Secretary Alex Azar denies a report that he and colleagues are plotting the ouster of FDA Commissioner Stephen Hahn over Hahn’s holding fast to stricter, more time-consuming rules for makers of novel COVID-19 vaccines than what the White House wants. Read More