FDA Commissioner Gottlieb provided a statement on the steps the agency is taking to strengthen and modernize the oversight
and reporting of inspections for sterile injectable drugs through its New Inspection Protocol Project (NIPP). FDA’s plan is to
implement the series of inspection protocols to cover all dosage forms within the next two years. [See IPQ September 28, 2015
for more on the development of NIPP and IPQ October 22, 2018 for an update on FDA’s current drug inspection and compliance
initiatives including NIPP.]
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