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FDA OKs Genentechs ACTPen Autoinjector

[ Price : $8.95]

FDA approves Genentechs ACTPen 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra (tocilizumab) as an additional form...

Clinical Hold Placed on Zafgen Diabetes Therapy

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FDA places a clinical hold on a Zafgen clinical trial of ZGN-1061, the companys second-generation, investigational MetAP2 inhibito...

Discussion Document on Patient Engagement in Device Trials

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FDA releases a discussion document on patient engagement in the medical device clinical trial process as a follow-up to its 10/201...

FDA Plans to Retire Outdated 510(k) Predicates

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FDA says it is examining ways to modernize the medical device 510(k) process by relying more on a review that weighs new technolog...

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 11/23/2018.

Comments on FDA Medical Device Servicing Report

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Four stakeholders comment on an FDA report on the servicing of medical devices.

AdvaMed Comments on Uncertainty Guidance

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AdvaMed submits line-by-line comments to FDA on a draft guidance on considering uncertainty in medical device benefit-risk determi...

Teva Used Priority Voucher for Migraine Drug

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Federal Register notice: FDA announces an approval for Tevas Ajovy (fremanezumab-vfrm) injection for preventing migraine in adults...

FDA Approves New Myeloid Treatment

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FDA approves Pfizers Daurismo to be used with low-dose cytarabine to treat some new cases of acute myeloid leukemia.

More Device Inspections Yields Better Compliance: CDRH

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A CDRH report says there is improved medical device manufacturer compliance as a result of increased inspection oversight using a ...