FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Discussion Document on Patient Engagement in Device Trials

[ Price : $8.95]

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FDA Plans to Retire Outdated 510(k) Predicates

[ Price : $8.95]

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

FDA-483 Issued After Cantrell Drug Co. Inspection

[ Price : $8.95]

FDA issues a Form FDA-483 after an August inspection of a Cantrell Drug Co. outsourcing facility in Little Rock, AR.

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...

FDA Accepts NDA for Sublingual Form of ALS Drug

[ Price : $8.95]

FDA accepts for review a Biohaven Pharmaceutical Holding Co. 505(b)(2) NDA for BHV-0223, an investigational sublingual form of ril...

Class 1 Recall of Oscor Pacing Leads

[ Price : $8.95]

FDA classifies as Class 1 an Oscor recall of its TB Temporary Bipolar Pacing Leads due to connector separation that may cause a lo...

Latest Federal Register Notices

[ Price : $8.95]

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

Comments on FDA Medical Device Servicing Report

[ Price : $8.95]

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

AdvaMed Comments on Uncertainty Guidance

[ Price : $8.95]

AdvaMed submits line-by-line comments to FDA on a draft guidance on considering uncertainty in medical device benefit-risk determi...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

[ Price : $8.95]

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