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Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Hubei Danjiangkou Danao Pharmaceutical and Vita-Pure.

Abuse-Deterrent Generic Opioid Guidance

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FDA commissioner Scott Gottlieb says the agency has issued a new guidance and taken other steps to help sponsors test and seek app...

Comments Sought on Info Collection Under 513(g) Devices

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Federal Register notice: FDA seeks comments on an information collection extension for 513(g) Request for Information OMB Control ...

Cytokinetics Suspends ALS Drug Program After Phase 3 Data

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Cytokinetics suspends its tirasemtiv drug development program after receiving disappointing data from the VITALITY-ALS Phase 3 cli...

Trintellix Not Withdrawn Due to Safety/Effectiveness: FDA

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Federal Register notice: FDA determines that Takedas Trintellix (vortioxetine hydrobromide) oral tablet, indicated for treating ma...

Comments Sought on Device Accredited Person Inspections

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Federal Register notice: FDA seeks comments on an information collection extension for its guidance on Notification of the Intent ...

2-drug Combination Approved for Treating HIV-1

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FDA approves a ViiV Healthcare NDA for Juluca, the first complete treatment regimen containing two drugs to treat certain adults w...

Clarification Wanted in Drug Benefit-Risk Guidance

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Stakeholders ask FDA for greater clarification on elements in its proposed framework for drug benefit-risk analysis.

Gottlieb to Testify on Cures Act Implementation

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The House Commerce Subcommittee on Health announces an 11/30 hearing on Implementing the 21st Century Cures Act: An Update from FD...

Groups Suggest Ways to Improve Waxman-Hatch

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Three industry representatives take different approaches to FDA efforts to restore a balance between innovation and generic drug a...