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Drugmakers have just over a year to comply with new Canadian regulations requiring evidence of GMP compliance at foreign facilities that make active pharmaceutical ingredients. Read More
Drugmakers should limit the amount of acetaminophen in pediatric liquid drugs to 160mg/5mL and include a statement highlighting the concentration on the container and labeling to reduce the chance of overdose, the FDA says. Read More
The Senate and House Appropriations Committees are calling on the FDA to issue guidance on biosimilars standards and work with industry to prevent drug shortages as part of their fiscal 2016 funding bills. Read More
Drugmakers want to know when changes to chemical, manufacturing and controls in ANDAs and other drug and biologics submissions must be reported to the FDA, saying draft guidance lacks clear criteria and examples. Read More
The FDA continues to crack down on generic drugmakers that owe GDUFA fees, hitting Indian drugmaker Vista Pharmaceuticals with a warning letter for failing to pay fees for the last three fiscal years. Read More
The list of states allowing substitution of biosimilars for prescription medicines nearly doubled in the first half of 2015, as seven states joined the list of eight that passed similar laws in 2013 and 2014. Read More