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If the product is mixed, diluted or repackaged in a state or federal pharmacy, it may only be distributed after receiving a valid prescription. Read More
The Drug Enforcement Administration issued a final rule expanding the types of practitioners who may temporarily prescribe narcotic drugs for opioid addiction treatment and improving treatment availability in underserved areas. Read More
CBER’s agenda for 2018 states that it is considering the release of more than a dozen guidance documents, including new draft guidance on testing retroviral gene therapy products and on hemophilia gene therapy, along with revisions to its draft guidance on reducing the risk of Zika virus transmission. Read More
Acceptable gifts include items designed for educational purposes, subsidized event registration fees and compensation for participation on advisory bodies or consulting arrangements. Read More
Congress voted Monday afternoon to re-open the government after failing to pass a stopgap measure over the weekend, which shut down federal agencies — but concerns remain about an upcoming standoff and the possibility of another shutdown in February. Read More
The FDA issued a final guidance on approved biologics that are mixed, diluted or repackaged, noting when the agency will not take action against violations of its standard rules on product misbranding and false and misleading labeling. Read More