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Substitutability of Generic Drugs: Perceptions and Reality; Public Workshop

The Food and Drug Administration (FDA), in collaboration with the Johns Hopkins University Center of Excellence in Regulatory Science and Innovation, is announcing a public work...

The Food and Drug Administration (FDA), in collaboration with the Johns Hopkins University Center of Excellence in Regulatory Science and Innovation, is announcing a public workshop entitled ``Substitutability of Generic Drugs: Perceptions and Reality.'' The objective of this workshop is to discuss FDA and industry practices related to postmarket surveillance of generic drugs, postmarket generic drug research activities, public perceptions of generic drug quality and effectiveness, and verification of therapeutic equivalence of generic drugs. This workshop will also give stakeholders, including scientists from government, academia, and industry, patient advocacy groups, clinicians, pharmacists, and the general public an opportunity to provide their insights on future research needs in postmarket surveillance of generic drugs.

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81 FR 71510

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“Substitutability of Generic Drugs: Perceptions and Reality; Public Workshop,” thefederalregister.org (October 17, 2016), https://thefederalregister.org/documents/2016-25004/substitutability-of-generic-drugs-perceptions-and-reality-public-workshop.