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Drug sponsors can prove the effectiveness of combination drugs for treatment of hypertension with trials that test the highest approved dosage rather than trials with multiple doses, the FDA said in new draft guidance for developing such products. Read More
The FDA issued a direct final rule removing the biennial inspection requirement for biologics production facilities and adopting a more flexible, risk-based approach to how often the agency will conduct inspections. Read More
The Food and Drug Administration teamed up with the Federal Trade Commission to issue joint warning letters to 11 marketers and distributors of opioid cessation products, for illegally marketing products with unproven claims of treating opioid addiction. Read More
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CBER’s agenda for 2018 states that it is considering the release of more than a dozen guidance documents, including new draft guidance on testing retroviral gene therapy products and on hemophilia gene therapy, along with revisions to its draft guidance on reducing the risk of Zika virus transmission.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