June 25, 2018

Vol. 15 No. 122

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White House Proposes Name Change for FDA

HHS also would get a new name — the Department of Health and Public Welfare. Read More

Consumer Group Calls for Withdrawal of Takeda’s Gout Treatment

A post-market clinical trial found higher all-cause and cardiovascular mortality in febuxostat-exposed subjects. Read More

NY Judge Rejects Opioid Makers’ Request for Dismissal of Eight Lawsuits

The judge rejected claims that FDA regulations preempt state law and that the companies are not accountable for doctor and pharmacist misconduct. Read More

FDA Pulls Biosimilar Analytics Guidance Amid Comments on Flexibility

Commenters questioned a requirement that lots come from U.S.-sourced reference products. Read More

FDA Issues Draft Guidance on Drug Development for Major Depressive Disorder

General toxicology studies should include a thorough evaluation of at least seven slices of the brain. Read More