REMS

FDA’s liver safety request set to delay decision on Travere’s kidney drug
FDA’s liver safety request set to delay decision on Travere’s kidney drug
Fierce Biotech
Travere Therapeutics
kidney disease
REMS
FDA
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FDA proposes plan to mail back unused opioids
FDA proposes plan to mail back unused opioids
RAPS.org
FDA
REMS
opioids
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FDA removes in-person dispensing requirement for abortion medication
FDA removes in-person dispensing requirement for abortion medication
RAPS.org
FDA
REMS
abortion pill
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FDA seeks comment on plan to increase REMS transparency
FDA seeks comment on plan to increase REMS transparency
RAPS.org
REMS
FDA
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Palforzia Peanut Allergy Immunotherapy: Aimmune CEO on REMS, Manufacturing
Palforzia Peanut Allergy Immunotherapy: Aimmune CEO on REMS, Manufacturing
Xconomy
Aimmune Therapeutics
Palforzia
drug launches
REMS
Jayson Dallas
drug manufacturing
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FDA Eliminates REMS for HIV Drug Truvada and its Generics
FDA Eliminates REMS for HIV Drug Truvada and its Generics
RAPS.org
FDA
Gilead Sciences
Truvada
HIV
REMS
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FDA reviewers: REMS could allay safety concerns for Sage's brexanolone
FDA reviewers: REMS could allay safety concerns for Sage's brexanolone
BioCentury
FDA
SAGE Therapeutics
postpartum depression
SAGE-547
brexanolone
REMS
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Drugmakers exploit REMS to restrict generics, and it doesn't bode well for biosimilars
Drugmakers exploit REMS to restrict generics, and it doesn't bode well for biosimilars
Fierce Pharma
REMS
generics
biosimilars
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A Bill Would Prevent Drug Makers From Frustrating Generic Rivals
A Bill Would Prevent Drug Makers From Frustrating Generic Rivals
WSJ Pharmalot
generics
REMS
patient safety
FDA
FTC
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