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Nuvectra Submits More Data on PMA for Virtis

[ Price : $8.95]

Nuvectra submits FDA-requested data to allow the agency to complete its review of a 2017-submitted PMA for Virtis for treating chr...

Teligent Generic OKd for Gentamicin Cream

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FDA has approved a Teligent ANDA for Gentamicin Sulfate Cream USP, 0.1%. The drug is used to treat minor skin infections (such as ...

End Medical Device Excise Tax: AdvaMed

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AdvaMed CEO Scott Whitaker asks President Trump to support permanent elimination of the medical device excise tax that is set to r...

Drug Quality Experiential Learning Site Visit Program

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Federal Register notice: FDA announces that it is accepting invitations to participate in the Fiscal Year 2020 CDER Office of Phar...

FDA/Health Canada ICH Public Meeting

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Federal Register notice: FDA announces an 11/4 regional public meeting between Health Canada and FDA on the International Council ...

CDRH Proposes 27 FY 2020 Final, Draft Guidances

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CDRH issues lists of final and draft guidances it expects to publish in FY 2020.

Nature City Settles FTC Claims for $537,500

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The Federal Trade Commission says a Florida federal court has approved a settlement with Nature City over the companys false and u...

Dont Use Cannabis When Pregnant, Breastfeeding: FDA

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FDA cautions against use of cannabis products by women who are pregnant or breastfeeding.

J&J, Ethicon Settle Mesh Marketing Suits for $116.9 Million

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Pennsylvania attorney general Josh Shapiro says Johnson & Johnson and its Ethicon subsidiary have settled allegations of deceptive...

Foamix Pharma NDA for Rosacea Foam Filed

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FDA accepts for review a Foamix Pharmaceuticals NDA for FMX103 (minocycline topical foam 1.5%) topical foam for treating moderate-...