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The FDA announced Friday that remote regulatory assessments (RRA) have proven to be a valuable tool and the agency will continue to use them beyond the COVID-19 pandemic. Read More
The FDA issued a proposed rule on Friday that would require drugmakers to use a standardized 12-digit National Drug Code (NDC) format with three distinct segments. Read More
The European Medicines Agency is calling for public comment on the International Council for Harmonization (ICH) new draft guidance on conducting drug interaction studies. Read More
“If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated,” said CDC Director Rochelle Walensky. Read More
Active pharmaceutical ingredient (API) manufacturer Bioiberica of Barcelona, Spain, was hit with a warning letter from the FDA for problems with contamination and lack of process controls. Read More
Labeling for proposed ready-to-use products that contain a range of drug strengths in a single container should contain instructions for determining the correct dose to be administered based on a patient’s weight or body surface area (BSA), according to a new FDA draft guidance. Read More