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FDA Clears Hybrid Sacroiliac Joint Implant

[ Price : $8.95]

FDA clears a Spinal Simplicity 510(k) for the Patriot-SI Posterior Implant System as part of a hybrid sacroiliac joint fusion cons...

Guide on Public Health Emergency IVDs

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Enforcement Policy for Certain In Vitro Diagnostic Devices ...

Test Enforcement Policies During Emergency Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Consideration of Enforcement Policies for Tests During a Se...

Update Informed Consent Guidance: AdvaMed

[ Price : $8.95]

AdvaMed calls for updates to FDA and HHS informed consent guidances.

High-Concentration Humira Biosimilar OKd

[ Price : $8.95]

FDA approves Boehringer Ingelheims high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), an interchangeable b...

Multiple Pinnacle BioLabs Violations Seen

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FDA warns Nashville, TN-based Pinnacle BioLabs that it is marketing and distributing a diagnostic test for an unapproved indicatio...

QS, MDR Violations at Future Diagnostics

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FDA warns Gelderland, Netherlands-based Future Diagnostics Solutions about Quality System and Medical Device Reporting violations ...

FTC Expands Junk Patent Challenges

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The Federal Trade Commission says it is expanding its challenges to junk drug patents with warnings to 10 companies about over 300...

Thiopurine Alert on Intrahepatic Cholestasis of Pregnancy

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FDA issues a safety alert on the rare risk of intrahepatic cholestasis of pregnancy associated with the use of thiopurines (azathi...

OND 55 Drug Approvals in 2023

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The CDER Office of New Drugs says it participated in 55 novel drug approvals in 2023.