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Drugmakers are pushing back against claims by newly-seated House Oversight Committee Chair Elijah Cummings (D-Md.) about their drug pricing practices, but say they will cooperate with the committee’s investigation. Read More
In anticipation of a surge of investigational new drug applications for cell and gene therapies in the next few years, FDA Commissioner Scott Gottlieb and CBER Director Peter Marks on Tuesday announced plans to issue new guidance to advance their development. Read More
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