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Comments Extended for Shared REMS Guide

[ Price : $8.95]

Federal Register notice: FDA reopens for 14 days the comment period on its draft guidance entitled Development of a Shared System ...

4 New Analgesic Guidances Coming

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FDA commissioner Scott Gottlieb says the agency will replace a 2014 guidance on developing new pain drugs with at least four separ...

Accord Healthcare Recalls 1 Hydrochlorothiazide Lot

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Accord Healthcare recalls one lot of hydrochlorothiazide tablets USP, 12.5 mg, due to a product labeling mix up.

FDA Accepts Evolus BLA Resubmission for DWP-450

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FDA accepts for review an Evolus BLA resubmission for DWP-450 (prabotulinumtoxinA) for treating glabellar lines, also known as fro...

Ortho NDA Resubmission for Psoriasis Lotion

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FDA accepts for review an Ortho Dermatologics NDA resubmission for Duobrii (halobetasol propionate and tazarotene) lotion, indicat...

Drug Complex Innovative Design Meeting Pilot

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FDA launches a complex innovative design pilot program for drug clinical trials.

Rule on Price Info in DTC Ads Illegal: WLF

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Washington Legal Foundation senior counsel Cory Andrews says FDA lacks authority to implement an HHS proposal to force drug manufa...

New Warning Added to Diabetes Drugs

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An FDA drug safety alert warns that cases of a rare and serious infection of the genital area have been reported with sodium-gluco...

Zimmer Biomet Warning Letter Posted

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FDA releases an 8/24 Zimmer Biomet Warning Letter that the company disclosed last week.

Complete Response Letter on Rare Disease Drug

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Ionis Pharmaceuticals and its affiliate Akcea Therapeutics receive an FDA complete response letter rejecting an NDA for Waylivra (...