Shared REMS: US FDA Wants Brisk Brand-Generic Talks, Might Give Unilateral Waivers
New draft guidances are an attempt to curb abuse of REMS single shared system process to delay generic entry.
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US FDA will list number of inquiries about acquiring samples for generic drug development, and also whether FDA sends letters to brand companies telling them it is safe to provide the generic sponsor with the samples.
To remain shielded from political forces that could change incentives, pharmaceutical industry must adopt 'a certain set of values,' US FDA Commissioner says.