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The Senate is considering a bill that would prohibit the federal government from restricting the sale and use of experimental, unapproved drugs for fatal illnesses. Read More
The House Committee on Energy and Commerce is examining the FDA’s Office of Criminal Investigations (OCI) over a variety of case management concerns. Read More
The FDA doesn’t have explicit penalties for failing to self-identify as a generic facility, but noncompliance can raise the likelihood of a pre-approval inspection, the agency said in a guidance document. Read More