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Three of the nation’s top medical experts heading up the nation’s response to COVID-19 are now in quarantine after being exposed to the coronavirus. Read More
The Office of Special Counsel (OSC) has recommended that Rick Bright be temporarily reinstated to his position as director of HHS’ Biomedical Advanced Research and Development Authority. Read More
Sponsors of drugs to treat or prevent cytomegalovirus (CMV) disease in organ or stem cell transplant patients may use CMV blood levels (CMV viremia) as a validated surrogate endpoint, according to a guidance the FDA finalized last week. Read More
Alexion has agreed in principle to settle with the Securities and Exchange Commission over an investigation into the company’s alleged bribery of foreign governments. Read More
How the federal government is handling the distribution of Gilead’s remdesivir for treatment of COVID-19 patients is sparking outrage and sharp criticism from physicians’ groups and doctors across the nation. Read More
The FDA accepted the BLA for the drug in February for priority review, and the agency was originally expected to approve the drug by Aug. 17, 2020. Read More
The former director of HHS’s Biomedical Advanced Research and Development Authority (BARDA) has filed a whistleblower complaint claiming he was removed from his role as head of the federal vaccine development agency in part for pushing for a more aggressive response to COVID-19. Read More
To keep prescription drugs moving smoothly through the supply chain during the pandemic, the FDA released emergency final guidance exempting certain COVID-19 products from tracing and identification requirements. Read More
CDER laid out how it will review newly identified safety signals (NISS) for marketed drugs, in a new Manual of Policies and Procedures (MAPP). Read More
The European Medicines Agency has introduced a new system for reporting drug shortages and potential supply chain disruptions as the COVID-19 pandemic takes a toll on the stock of some critical medicines. Read More
The European Medicines Agency (EMA) recommended that good manufacturing practice (GMP) certificates for drugmakers be extended until the end of 2021 to avoid potential drug supply-chain disruptions during the pandemic. Read More
A Federal appeals court has upheld the FDA’s denial of a new drug application for an abuse-deterrent formulation of oxycodone from Pharmaceutical Manufacturing Research Services (PMRS). Read More