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…
A federal circuit court upheld a PTO Patent Trial and Appeal Board ruling that a Johnson & Johnson patent for Remicade, which earned the company nearly $7 billion in 2016,…
The Senate voted 55 to 43 on Wednesday to confirm former pharmaceutical industry executive Alex Azar as HHS secretary. Source: Drug Industry Daily
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…
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.…
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.…
CBER’s agenda for 2018 states that it is considering the release of more than a dozen guidance documents, including new draft guidance on testing retroviral gene therapy products and on…
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…
The FDA issued drugmaker Milan Laboratories (India) a Form 483 over quality and sanitation problems observed during an August inspection of the firm’s Navi Mumbai facility. Source: Drug Industry Daily
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…