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CDRH Listing on Upcoming Guidance Documents

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Federal Register notice: FDA announces its Web site address where CDRH will post two lists of guidance documents that the Center i...

Info Collection on 510(k) 3rd-party Reviews

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Federal Register notice: FDA submits to OMB an information collection extension for 510(k) Third-Party Review Program.

Innoveix Pharma Recalls Drugs Over Sterility Concerns

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Innoveix Pharmaceuticals recalls all sterile compounded drug products due to sterility assurance concerns.

Info Collection Extension for CVM eSubmissions

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Federal Register notice: FDA sends to OMB an information collection extension for a guidance on cvms electronic submission system....

FDA Hits Cipla in India with 38-page Form-483

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FDA issues a highly redacted 38-page Form-483 following a recent inspection at drug manufacturer Cipla in Goa, India.

Lillys Reyvow Approved for Migraines

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FDA approves Eli Lillys Reyvow (lasmiditan) tablets for the acute treatment of migraine with or without aura in adults.

FDA Clears Think Surgical Robotic Knee Replacement

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FDA clears a Think Surgical 510(k) for the TSolution One Total Knee Application for use in total knee arthroplasty.

JAMA Article Raises Doubt on Replicating Trials

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A new study in JAMA suggests there is limited feasibility for the idea of replicating clinical trials using real-world evidence.

FDA Clears Turn Therapeutics Wound Dressing

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FDA clears a Turn Therapeutics 510(k) for the Protego Antimicrobial Wound Dressing.

7 Observations on Aurobindo FDA-483

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FDA releases an FDA-483 with seven observations from an inspection at an Aurobindo finished drug manufacturing facility.