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FDA Updates Compounder PPE Guidance

[ Price : $8.95]

FDA updates a guidance to explain how sterile compounded drugs can be prepared in a segregated compounding area if standard person...

FDA Posts Thermal Imaging Web Resource

[ Price : $8.95]

FDA posts a Web resource page on using thermal imaging systems for temperature screening during Covid-19.

QS, MDR Violations at Ideal Implant

[ Price : $8.95]

FDA warns Ideal Implants about QS and MDR violations in its manufacturing of saline-filled breast implants.

Allergan Missing Breast Implant Study Requirements

[ Price : $8.95]

FDA warns Allergan that it is not complying with post-approval study requirements for two styles of silicone breast implants.

FDA Withdrawing Approval of 16 NDAs

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of 16 NDAs from multiple applicants after they notified the agency that the drug p...

Zealand Pharma NDA Filed for Diabetes Rescue Pen

[ Price : $8.95]

Zealand Pharma submits an NDA for HypoPal (dasiglucagon) rescue pen for treating diabetes patients with severe hypoglycemia.

Abbott Covid-19 Test Has High False Negatives: Study

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New York University researchers say that a comparative study showed that Abbott Laboratories ID Now Covid-19 rapid test missed a t...

Sparrow Health Selling Unapproved Cell Products: CBER

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A CBER notice of violation says Sparrow Health & Performance is providing unapproved adipose tissue-derived cellular products to t...

Info Collection Extension on MedSun Reporting

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Federal Register notice: FDA sends to OMB an information collection extension for Adverse Event Program for Medical Devices (Medic...

Info Collection on Certifications for Product Submissions

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Federal Register notice: FDA seeks comments on an information collection extension entitled Certification to Accompany Drug, Biolo...