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Wong Lap Kwong Medicine Company drew a warning from the FDA for failing to identify active pharmaceutical ingredients and to establish procedures for numerous basic functions in its Hong Kong facility. Read More
A drug research firm is suing the FDA for $50 million, arguing the agency issued a disciplinary letter that “annihilated” the company based on evidence fabricated by a rogue employee. 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CBER’s agenda for 2018 states that it is considering the release of more than a dozen guidance documents, including new draft guidance on testing retroviral gene therapy products and on hemophilia gene therapy, along with revisions to its draft guidance on reducing the risk of Zika virus transmission.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
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