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The FDA released draft guidance Wednesday for companies seeking amendments or final approval for tentatively approved ANDAs — the first guidance to emerge during the partial government shutdown. Read More
The new office will use tools such as biomarkers, biomedical informatics and real-world evidence as more integral components of the drug review process. Read More
Sentinel is “a critical engine for methodological innovation and a platform to advance the science of real world evidence,” Commissioner Gottlieb said. Read More
The American Hospital Association urged the FDA to seek authority from Congress to require more stringent disclosures by drugmakers to help limit prescription drug shortages. Read More
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