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The study plans will be necessary for supplemental applications for a new indication, new dosage form, new dosing regimen, or new route of administration, unless the drug is for an indication with orphan status. Read More
The European Medicines Agency issued a draft paper to clarify the responsibilities of marketing authorization holders (MAHs) under the EU’s GMP regulations, which the EMA conceded can be confusing. Read More
According to the Department of Justice, the Insys executives allegedly bribed doctors to prescribe fentanyl-based medication, often to patients who didn’t need it.
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The Drug Enforcement Administration (DEA) should expedite two new regulations to make opioid addiction treatments more readily available, three Democratic lawmakers said, noting that the agency was supposed to have issued such rules by October 2019. Read More
The third phase of restructuring at the Office of New Drugs is underway, setting up an Office of Nonprescription Drugs and an Office of Specialty Medicine. Read More
“The companies engaged in reckless behavior and need to be held accountable for their role in creating the nation’s worst manmade public health crisis,” state attorney general Mike Hunter said. Read More
A congressional committee may be planning to throw its weight behind “complex generics” as part of a push to increase generic options and lower drug costs. Read More
The Government Accountability Office (GAO) laid out policy options for dealing with the challenges of machine learning in drug development in a report released yesterday — noting that uncertainty about potential regulation of machine learning is hindering its adoption. Read More