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10 Observations on Fujifilm Diosynth FDA-483

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FDA releases an FDA-483 with 10 observations from an inspection at the Fujifilm Diosynth Biotechnologies drug substance manufactur...

FDA Warns UK Face Mask Marketer

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FDA issues a Warning Letter to Invisi Smart Technologies (United Kingdom) over its Invisi Smart Mask for sale in the U.S. without ...

Amneal Plans Parkinsons NDA for IPX-203

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Amneal Pharmaceuticals says it will file an NDA for IPX-203 in mid-2022, after reporting positive topline results from a Phase 3 c...

eCTD Submisson Rejections Due to Validation Failures

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Federal Register notice: FDA announces that beginning 3/1/2022 it will reject Electronic Common Technical Document submissions tha...

Comments Sought on Environmental Impact Considerations

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Federal Register notice: FDA seeks comments on an information collection extension entitled Environmental Impact Considerations (O...

Baxter Spectrum Pump Urgent Correction

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Baxter says it expects to deploy a software upgrade for its Spectrum IQ infusion pumps in the fourth quarter to address an issue e...

Labeling for AI/Machine Learning Devices Workshop

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FDA announces a 10/14 virtual public workshop on improving transparency of artificial intelligence/machine learning-enabled medica...

Stealth Submits Elamipretide NDA Over FDA Concerns

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Stealth BioTherapeutics says it has acceded to Barth syndrome patient community requests and submitted an NDA for elamipretide des...

10 Accelerated Approval Reforms Evaluated

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Researchers evaluate 10 possible reforms to the FDA accelerated approval pathway.

PD-1/PD-L1 Alternative Dosing Regimen Draft Guidance

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FDA publishes a draft guidance on a pharmacokinetic approach to alternative dosing regimens for PD-1 and PD-L1 drugs.