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Microspecialties Quality System Issues

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FDA warns Middletown, CT-based Microspecialties about Quality System violations in its work as a contract manufacturer of several ...

Expand mRNA Covid Vaccine Warnings: FDA

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FDA tells Pfizer and Moderna to strengthen the Warnings in their Covid-19 vaccines related to a possible adverse heart effect in y...

Bipartisan Bill to Codify Trump Drug Price Order

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Four House members introduce bipartisan legislation to legalize major provisions in President Trumps drug pricing executive order....

Panel is Split on UroGens Bladder Cancer Drug

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FDAs Oncologic Drugs Advisory Committee offers a split vote on whether UroGen Pharmas NDA for mitomycin intravesical solution demo...

Zynex Files 510(k) for CO-Oximeter Device

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Zynex files a 510(k) for its NiCO, Noninvasive CO-Oximeter device that relies on the companys laser technology.

48 New, Revised PSGs Out

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FDA publishes 34 new and 14 revised product-specific guidances to aid in generic drug development.

Miller Named Acting Inspections Chief

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FDA names Elizabeth Miller acting associate commissioner of the Office of Inspections and Investigations (OII), replacing Michael ...

FDA Warns Sarfez About Soaanz Promotional Materials

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The CDER Office of Prescription Drug Promotion warns Sarfez Pharmaceuticals that promotional materials for its Soaanz edema drug c...

Covid Vaccine Policy on Boosters and New Trials

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FDA commissioner Marty Makary and CBER director Vinay Prasad outline a new regulatory framework for annual Covid-19 booster shots...

SSRI/SNRI Labeling Changes Sought

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The Antidepressant Coalition for Education petitions FDA to change labeling for selective serotonin reuptake inhibitors and seroto...