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Guanfacine OK for ANDAs: FDA

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Federal Register notice: FDA determines that Promius Pharmas Tenex (guanfacine HCl) tablets, 1mg, 2mg,and 3mg were not withdrawn f...

FDA Continues to Meet Product Review Goals: Hahn

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FDA commissioner Stephen Hahn praises agency medical product review staff for maintaining the pace of reviews and actions during t...

House Committee Wants Covid Vaccine Transparency

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Democratic leaders of the House Committee on Oversight and Reform ask FDA for a briefing on plans for coronavirus vaccine transpar...

Covid Drug Manufacturing Guidance Explained

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Two SheppardMullin attorneys discuss provisions in an FDA guidance on preventing coronavirus contamination of drugs, biologics, an...

Comments Urge Changes to Emergency-Use Injectors Guide

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Hyman, Phelps & McNamara asks FDA to provide examples to clarify specific items in the agencys draft guidance on emergency-use inj...

FDA Approves Karyopharm sNDA for Xpovio

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FDA approves a Karyopharm Therapeutics supplemental NDA for Xpovio (selinexor), a selective inhibitor of nuclear export compound f...

FDA Alert on Mexican Hand Sanitizers

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FDA issues a safety alert on hand sanitizers manufactured by Eskbiochem SA de CV in Mexico due to the potential presence of methan...

Senate Bill to Reauthorize Pediatric Voucher Program

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Senators Bob Casey (D-PA) and Susan Collins (R-ME) introduce the Creating Hope Reauthorization Act (S 4010) that would permanently...

CVM Export Certification Online System

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FDAs Center for Veterinary Medicine launches its Export Certification Application and Tracking System, a new online system that al...

Guide on Covid Effects on Device User Fee Activities

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FDA issues a guidance on Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical ...