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The FDA’s Office of Regulatory Affairs (ORA) has determined that general and prioritized inspections will remain preannounced for the foreseeable future in order to ensure the safety of those involved during the pandemic, according to a regulatory official. Read More
The FDA is very likely to grant Emergency Use Authorization (EUA) for Pfizer’s COVID-19 vaccine following a 17-4 advisory committee vote (with one abstention) Thursday in support of emergency clearance, meaning vaccinations of high-risk patients could start as soon as this weekend. Read More
The advocacy group Public Citizen said Wednesday that it had written to the HHS’ Office of Inspector General urging it to “investigate the unprecedented and inappropriate close collaboration” between the FDA and Biogen over the company’s biologics license application (BLA) for approval of the potential blockbuster Alzheimer’s drug aducanumab. Read More
Azurity Pharmaceuticals downplayed the serious risks and overstated the benefits of its leukemia drug Xatmep (methotrexate) oral solution in the text of a promotional email sent to healthcare professionals, according to a Nov. 24 “untitled letter” from the agency’s Office of Prescription Drug Promotion (OPDP). Read More
The FDA is working on a report tied to a two-day meeting this week to discuss its pilot program on pharmaceutical supply chain interoperability, as well as other efforts to modernize the drug supply chain in the U.S. It has not set a release date for the report. Read More
A cystic fibrosis (CF) advocacy group has levied a formal complaint with the United Nations (UN), charging that Vertex Pharmaceuticals is violating the world body’s guidelines by unfairly pricing its CF drugs and not ensuring widespread equitable access. Read More
FDA today said it is publishing two guidances focused on maintaining compliance with the agency’s mislabeling regulations as well as how best to name new drugs so that consumers can avoid medication errors. Read More
An FDA Emergency Use Authorization (EUA) could come as soon as this weekend for Pfizer/BioNTech’s COVID-19 vaccine, with the vaccine advisory committee set to meet tomorrow to discuss the agency’s 53-page analysis concluding that the two-dose regimen met its strict EUA requirements. Read More
As accusations fly that the Trump administration passed on securing doses of Pfizer’s highly effective COVID-19 vaccine beyond an initial supply contract, the president signed an executive order Tuesday that intends to prioritize American access to vaccines supported or procured by the government and threatened to invoke emergency legislation, if needed, to bolster supplies. Read More
PhRMA and BIO have filed lawsuits in an attempt to thwart the Trump administration’s most favored nations policy, a drug pricing measure unpopular with the pharma industry that will soon come into effect, and the litigation is likely to delay the policy’s implementation. Read More