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Draft Guide on PD-1, PD-L1 Alternative Dosing

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Federal Register notice: FDA makes available a draft guidance entitled Pharmacokinetic-Based Criteria for Supporting Alternative D...

FDA Approves Expanded Age for Ironwoods Linzess

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FDA approves a revised label for Ironwoods Linzess expanding the potential for off-label use in children under age 18.

Court Tosses Boston Scientific Whistleblower Case

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Three Sidley Austin attorneys describe a Minnesota federal court decision rejecting a whistleblowers claims that Boston Scientific...

FDA OKs Expanded Tibsovo Indication Plus Diagnostic Test

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FDA approves an expanded indication for Serviers Tibsovo plus a companion diagnostic test to identify patients for the new indicat...

Takeda Illegally Extended Actos Patents: Court

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The 2nd Circuit Appeals Court says antitrust suits alleging that Takeda illegally delayed generic entry of its diabetes drug Actos...

Fuse Medical 510(k) for Knee System

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FDA clears a Fuse Medical 510(k) for its Tibial Revision Knee System and the PS Plus Posterior Stabilized Tibial Insert.

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...