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PhRMA Urges FDA Halt to CMC Reporting Guidance

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Pharmaceutical Research and Manufacturers of America says FDA should halt efforts on finalizing its draft guidance on Established ...

FDA Safety Alert on LEO Labs Picato Gel

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FDA issues a drug safety alert on LEO Labs Picato gel (ingenol mebutate) due to reports of severe allergic reactions and herpes zo...

Positive Data from 2 Pfizer Trumenba Studies

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Pfizer says two Phase 3 studies involving Trumenba (meningococcal Group B vaccine) met all primary immunogenicity endpoints in pat...

UDI Account Requests for Life-supporting Implants

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CDRH says that in January it will begin accepting Global Unique Device Identification Database account requests from labelers of i...

Public Meeting on Breast Cancer Drug Development

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Federal Register Notice: FDA plans a public meeting 4/2 on patient-focused drug development for breast cancer.

FDA Clears Roxwood Medicals CenterCross Catheter

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FDA clears a Roxwood Medical 510(k) for the CenterCross Catheter and its use in the coronary and peripheral vasculature.

FDA Accelerated Approval for AstraZenecas Lynparza

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FDA grants accelerated approval for an AstraZeneca NDA for Lynparza (olaparib) and its use in treating women with advanced ovarian...

PhRMA Concerned on REMS Training as Part of Continuing Education

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Pharmaceutical Research and Manufacturers of America says it is highly concerned about FDAs plans to focus on risk evaluation and ...

FDA Asks Herbalife to Pull Misleading Video

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FDA asks Herbalife to stop running a broadcast advertisement and YouTube video that mischaracterizes the agencys regulatory role w...

FDA Plans Conference on Drug-Induced Liver Injuries

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Federal Register Notice: FDA plans a public conference 3/18-19/15 on serious drug-induced livery injuries.