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Biologics Companies Cutting Production Costs: White Paper

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A Tufts Center for the Study of Drug Development roundtable discussion finds that innovative biologics manufacturing is cutting co...

FDA Info Collection Extension for eRecords

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Federal Register notice: FDA seeks comments on an information collection extension for Electronic Records; Electronic Signatures O...

Regeneron Not Moving Eye Drug Combo Into Phase 3

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Regeneron Pharmaceuticals says two Phase 2 studies looking at adding investigational drug nesvacumab to the companys already-appro...

Comments Sought on Export Certificates Info Collection

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Federal Register notice: FDA seeks comments on an information collection extension for Export of FDA-Regulated Products: Export Ce...

Sen. Schumer Seeks FTC Review on Home DNA Kits

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Sen. Chuck Schumer (D-NY) calls on the Federal Trade Commission to examine direct-to-consumer home DNA kits to ensure genetic info...

Draft Guide on Grandfathering Drugs Sans Product Identifiers

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Federal Register notice: FDA makes available a draft guidance entitled Grandfathering Policy for Packages and Homogenous Cases of ...

Workshop on IND Safety Assessment Reporting

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Federal Register notice: FDA announces a 1/11/2018 public workshop entitled Safety Assessment for IND Safety Reporting.

Sun Pharma Recalls 2 Riomet Contaminated Lots

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Sun Pharmaceutical Industries recalls two lots of Riomet (metformin hydrochloride oral solution), 500 mg/5mL, due to Scopulariopsi...

Pediatric X-ray Guidance for 510(k) Submissions

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FDA posts a guidance on Pediatric Information for X-ray Imaging Device Premarket Notifications that outlines the agencys current t...

BioMarin Sells Priority Review for $125 Million

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BioMarin Pharmaceutical agrees to sell for $125 million its Rare Pediatric Disease Priority Review Voucher it was awarded by FDA i...