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Draft Guide on Drug Master Files

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Federal Register notice: FDA makes available a draft guidance entitled Drug Master Files.

10 Info Collections Approved by OMB

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Federal Register notice: FDA is publishing a list of information collections that have been recently approved by OMB.

American Gene Tech IND for HIV Gene Therapy

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American Gene Technologies files an IND for its lead HIV program, AGT103-T, a single-dose, lentiviral vector-based gene therapy be...

J&J Recalls Baby Powder Due to Asbestos

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FDA says Johnson & Johnson has recalled one lot of its Johnsons Baby Powder (Lot #22318RB) after an agency sample detected asbesto...

Nuvectra Submits More Data on PMA for Virtis

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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.