Generic Labeling Rule Defies Predictions, Remains In FDA's Long-Term Pipeline
Executive Summary
Policy that would allow generic sponsors to change product labels has been delayed yet again, not spiked completely, even with Commissioner Gottlieb's known opposition to the rule.
You may also be interested in...
OTC Drug Irradiation Rule Exposed As Unnecessary In FDA Regulatory Review
US FDA proposes to repeal regulation that, since 1955, has required an NDA or ANDA for any drug product sterilized by irradiation, including drugs that otherwise would be marketed under an OTC monograph. It notes the Trump administration's order that federal agencies identify and potentially eliminate any unnecessary rules and regulations.
OTC Drug Irradiation Rule Exposed As Unnecessary In FDA Regulatory Review
US FDA proposes to repeal regulation that, since 1955, has required an NDA or ANDA for any drug product sterilized by irradiation, including drugs that otherwise would be marketed under an OTC monograph. It notes the Trump administration's order that federal agencies identify and potentially eliminate any unnecessary rules and regulations.
US FDA's Regulatory Pipeline Includes DTC, Inspection Requirement Updates
Additionally, potential regulation to require clinical study sponsors to promptly report suspected data falsification seems to have found new life after being listed as inactive in July update of the Unified Agenda.