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Draft Guidance on Best Practices for IND Sponsor/FDA Talks

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FDA posts a draft guidance on Best Practices for Communication Between IND Sponsors and FDA During Drug Development.

ADC Therapeutics IND for Antibody Drug Conjugate Cleared

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FDA clears an ADC Therapeutics IND to begin clinical trials with ADCT-402, a novel antibody drug conjugate targeting CD19, a cell-...

Trevena Given Fast Track for Novel Pain Drug

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FDA grants Trevena a fast track designation for oliceridine (TRV130) for managing moderate-to-severe acute pain.

Sun Pharma Gains FDA OK for Generic Gleevec

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FDA approves a Sun Pharmaceutical Industries ANDA for generic versions of Novartis chronic myeloid leukemia treatment Gleevec (ima...

FDA Alert Warns About Lipo Escultura

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An FDA safety alert says Lipo Escultura Corp. (Brooklyn, NY) is recalling all Lipo Escultura dietary supplement products because, ...

CDRH Safety Communications Up

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Qmed Daily says the number of CDRH medical device safety communications this year rose substantially over the numbers in 2014 and ...

CBE Rule Delay Risking Generic Drug Patients: Public Citizen

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Public Citizen calls on FDA to quickly finalize its proposed rule to allow generic drug manufacturers to update safety warnings wi...

eCopy Program Submission Guidance

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FDA issues an updated final guidance on eCopy submission standards for medical devices.

Start Quality Metrics Targeted Program: ISPE

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The International Society for Pharmaceutical Engineering calls on FDA to use a targeted, phased-in approach to start its quality m...

FasterCures Suggestions for Patient Perspective Info

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FasterCures recommends PDUFA 6 language to build collection of patient perspective data into medical product development and regul...