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Guide on ANDA Cover Letter Attachments

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Cover Letter Attachments for Controlled Correspondence and ...

FDA Withdraws Approval of Vintage Pharma ANDA

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Federal Register notice: FDA withdraws approval of a Vintage Pharmaceuticals ANDA for pemoline tablets after the company requested...

Priority Review Voucher Awarded to Krystal Bio

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Federal Register notice: FDA issues a priority review voucher to Krystal Biotech in response to an approved rare pediatric disease...

Updated ICH Good Clinical Practice Guidance

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FDA publishes an International Council for Harmonization draft guidance on good clinical practices intended to improve clinical tr...

Multiple Violations at Steiner Biotechnology

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FDA warns Henderson, NV-based Steiner Biotechnology about multiple violations in its production and labeling of several dental bon...

GSK File sBLA for Jemperli in Endometrial Cancer

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FDA accepts for review a GSK supplemental BLA for Jemperli (dostarlimab) in combination with chemotherapy for treating certain adu...

iRhythm Technologies Cited for Unapproved Device

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FDA warns Cypress, CA-based iRhythm Technologies about multiple violations in its production of the ZIO AT cardiac event reporting...

1st De Novo Authorization for Covid Test

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FDA grants a de novo marketing authorization for Cue Healths Cue Covid-19 Molecular Test, the first at-home Covid test granted a t...

Norwich Sues FDA Over Rifaximin ANDA

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Norwich Pharmaceuticals asks the DC federal court to order FDA to grant final approval to the companys amended ANDA for generic ri...

PhRMA Agrees with Discontinuance Recommendations

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PhRMA says it generally agrees with recommendations in an FDA draft guidance on notification of a permanent discontinuance or inte...