The 52 comments the FDA received during the public commentary period on the agency’s January 2017 draft guidance, Considerations in Demonstrating Interchangeability With a Reference Product, included statements from physicians concerned about the proposed policy.
The 52 comments the FDA received during the public commentary period on the agency’s January 2017 draft guidance, Considerations in Demonstrating Interchangeability With a Reference Product, included statements from physicians concerned about the proposed policy.
The physicians represented organizations including the Coalition of State Rheumatology Organizations (CSRO), the American Society of Clinical Oncology (ASCO), the American Gastroenterological Association (AGA), the American Academy of Dermatology Association (AADA), and the American Autoimmune Related Diseases Association (AARDA), who widely prescribe biologic drugs to their patients.
Physician concerns included the extrapolation of indications, switching, labeling, naming, postmarketing studies, and the agency’s engagement of disease experts when interchangeable products are reviewed for approval.
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