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BIO Suggests Improvements to 3 Covid-19 Guidances

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BIO discusses how three FDA emergency Covid-19 guidances may inform future inspection practices after the public health emergency ...

FDA OKs Tanovea for Lymphoma in Dogs

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FDA approves VetDCs Tanovea (rabacfosadine injection) to treat lymphoma in dogs.

FDA Safety Concerns with NuVasive MAGEC Implants

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FDA says it is working with NuVasive to resolve safety issues with its MAGEC growing spinal rod system.

Scarsdale Integrative Marketing Unapproved Cell Products: FDA

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The CBER Office of Compliance and Biologics Quality cautions Scarsdale Integrative Family Medicine that it is marketing unapproved...

Stromectol Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Mercks Stromectol (ivermectin) tablets, 6 mg, were not withdrawn from sale for reason...

False, Misleading Claims in Neulasta Professional Animated Banner: OPDP

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CDERs Office of Prescription Drug Promotion says a professional promotional banner for Neulasta gives false and misleading claims ...

FDA Denies Janssen Invega Sustenna Petition

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FDA denies a Janssen petition seeking to impose restrictions on ANDAs and NDAs citing the companys Invega Sustenna as the referenc...

FDA Lifts Hold on Ryvu Myeloid Leukemia Trial

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FDA lifts a partial clinical hold against Ryvu Therapeutics and its Phase 1b dose escalation clinical trial of RVU120 (also known ...

Petition Asks FDA to Reject Tyvaso Without Specific Info

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An unidentified petitioner asks FDA not to approve an NDA for United Therapeutics Tyvaso DPI without trial results showing it is s...

Woodcock: Aduhelm Process Could Have Been Better

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Acting FDA commissioner Janet Woodcock defends the agencys Aduhelm approval but says the process could have been handled less cont...