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The Center for Drug Evaluation and Research (CDER) highlights efforts to deal with drug shortages, sham COVID-19 products and poorly compounded drugs, as well as its enforcement successes amidst the pandemic, in its latest annual report from its Office of Compliance, released yesterday. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) plans to resume in-person inspections of drug facilities starting March 29 but it will adopt a hybrid approach that allows for both remote and on-site elements. Read More
The European Medicines Agency (EMA) has advised against the use of Merck’s anti-parasitic drug Stromectol (ivermectin) for the prevention and treatment of COVID-19. Read More
As the EU’s COVID-19 vaccine supply woes intensify, the 27-member bloc is signaling it could make good on its threat to halt exports of vaccine doses to the UK as soon as this week. Read More
The FDA has promised transparency as it implements data and technology modernization initiatives in its latest discussions with industry ahead of the next reauthorization of the Prescription Drug User Fee Act (PDUFA). Read More
PhRMA is still battling a final rule from the Trump Administration era to allow in pharmaceuticals from Canada and has filed a citizen’s petition asking the FDA to block New Mexico’s plan for importing drugs. Read More
The FDA’s Center for Biologics Evaluation and Research (CBER) has released a five-year strategic plan for 2021-2025 that outlines in broad terms how the center will use advances in science and technology — including increased use of real-world data (RWD) in clinical trials — to help achieve four main goals. Read More
HHS is postponing implementation of a final rule issued late in the Trump administration that would have required the FDA to review practically every regulation it has and redirect resources away from pandemic relief efforts. Read More