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FDA activities that most directly impact safety will continue “to the best of our abilities, subject to the legal and financial limitations of the current circumstances,” Gottlieb said. Read More
Louisiana’s Department of Health is seeking a drug manufacturing partner willing to adopt a Netflix-style subscription model for hepatitis C drugs. Read More
As the partial government shutdown entered a record-setting fourth week, FDA Commissioner Scott Gottlieb said it was no longer “business as usual” at the agency — calling the shutdown “one of the most significant operational challenges in FDA’s recent history.” He said the agency is now designating more activities as “excepted, unpaid work.” Read More
MHRA said medicines purchased outside the regulated supply chain cannot be guaranteed to meet standards of quality, safety and effectiveness. Read More
The motion for a gag order alleges DeWine and attorneys Mike Moore and Burton LeBlanc conspired to use misleading and inflammatory pronouncements to taint potential jury pools. Read More
The FDA is considering new formats to replace the five-digit National Drug Code (NDC) and drugmakers — at least those who commented on the agency’s proposals — prefer extending the code to 12 digits. Read More
A Connecticut Superior Court judge dismissed dozens of lawsuits by cities and towns in the state against Purdue and other drugmakers for their alleged role in the opioid crisis. Read More
A joint FDA advisory committee voted 19 to two on Friday in favor of the benefit-risk profile of Takeda’s Uloric (febuxostat) for treatment of excessive uric acid in the blood of gout patients. Read More
U.S. District Judge Theodore Chuang shot down the defendants’ arguments that a recent Supreme Court decision protecting foreign firms against U.S. lawsuits also extended to domestic corporations, allowing the litigation to go forward. Read More