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Rule on Cigarette Health Warnings

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Federal Register notice: FDA issues a final rule to establish new health warnings for cigarette packages and advertisements.

Comments Reopened on Shared REMS Guide

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Federal Register notice: FDA reopens the comment period for a 6/1/2018 notice on a shared system risk evaluation and mitigation st...

CDER Postpones, Cancels and Modifies Meetings

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Federal Register notice: CDER lists certain meetings from 3/10 through 4/30 that are postponed, canceled, or modified to take plac...

FDA Looks for Coronavirus Test Info on Twitter

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Politico says FDA is turning to Twitter to request information on Covid-19 testing supplies from medical device manufacturers.

Epclusa Pediatric Label Changes Approved

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FDA approves changes to Gileads Epclusa labeling to include specific pediatric use.

Stakeholders Seek Changes in Effectiveness Guidance

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Three stakeholders suggest changes to an FDA draft guidance on demonstrating substantial evidence of effectiveness for human drug ...

FDA Looks at Repurposing Older Drugs for Outbreak

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FDA commissioner Stephen Hahn says that FDA is looking at repurposing older drugs to treat or prevent coronavirus.

17 Issues In Invitrx Inspection

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FDA warns Invigtrx Therapeutics about 17 deficiencies in its processing of products for allogeneic use.

Mallinckrodt Rolling NDA for Terlipressin

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Mallinckrodt completes a rolling NDA submission for terlipressin, an investigational agent being evaluated for treating hepatorena...