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FDA Lifts Clinical Hold on Hemophilia Drug

[ Price : $8.95]

FDA lifts a clinical hold on Alnylam Pharmaceuticals clinical studies with fitusiran, indicated for treating patients with hemophi...

Draft Guide on Device Least Burdensome

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Federal Register notice: FDA makes available a draft guidance entitled The Least Burdensome Provisions: Concept and Principles tha...

Priority Review Voucher for Ultragenyx Pharma

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Federal Register notice: FDA issues a priority review voucher to Ultragenyx Pharmaceutical for obtaining approval of a rare pediat...

FDA Changes Date of IND Safety Reporting Workshop

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Federal Register correction notice: FDA corrects an 11/27 notice entitled Safety Assessment for Investigational New Drug Safety Re...

POGO Implicates Gottlieb in Amicus Drugs FDA Review Advance

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Citing correspondence addressed to then-new commissioner Scott Gottlieb, the Project On Government Oversight questions how biotech...

Medtronic Settles Infuse Case for $12 Million with States

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Medtronic agrees to a $12 million settlement with five states over alleged deceptive promotion of its Infuse bone graft system.

FDA Issues Least Burdensome Guidance

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FDA publishes a draft guidance explaining its view of Congress requirement that it apply least burdensome principles to medical de...

High Throughput Sequencing Can be Standardized: FDA Research

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FDA scientists say it is possible to standardize high throughput sequencing to screen biologics for contamination.

Comments on PDMA Information Collection Extension

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Federal Register notice: FDA seeks comments on an information collection extension for Prescription Drug Marketing Act of 1987 Ad...

Comments Sought on GMP Info Collection Extension

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Federal Register notice: FDA seeks comments on an information collection extension for Current Good Manufacturing Practice Regulat...