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Estimate Device Malfunction Risk Carefully: Attorney

[ Price : $8.95]

Attorney Jeffrey Shapiro says companies should be careful when calculating for FDA the risk of a medical device malfunction.

Total Product Lifecycle in Cyber Guidance

[ Price : $8.95]

A CDRH official says a new draft cybersecurity guidance has teeth that make it more likely that companies that follow its recommen...

FDA Nixes Indication on Securas Copiktra

[ Price : $8.95]

Federal Register notice: FDA announces that it is withdrawing approval of a Secura Bio indication for Copiktra (duvelisib) for tre...

Hold on Covid-19 Vaccine After WHO Inspection

[ Price : $8.95]

FDA places a clinical hold on an Ocugen Phase 2/3 immuno-bridging and broadening study for its Covid-19 vaccine Covaxin (BBV152) a...

BIMO Metrics Show Major Inspection Declines

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FDAs Bioresearch Monitoring Program metrics report for fiscal year (FY) 2021 shows substantially fewer clinical investigator and I...

Comments on Discontinuance/Interruption Guidance

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Four medical device stakeholders call for changes to an FDA draft guidance on notifying the agency in advance of a public health e...

Improvements Suggested for Non-Opioid Analgesic Guidance

[ Price : $8.95]

Two stakeholders suggest changes to an FDA draft guidance on developing non-opioid analgesics for acute pain.

Myovant/Pfizer Myfembree sNDA Has Deficiencies: FDA

[ Price : $8.95]

Myovant Sciences and Pfizer say FDA has told them that it found deficiencies in a supplemental NDA on Myfembree (relugolix 40 mg, ...

Google Fitbit Algorithm Cleared for AFib

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FDA clears a Google 510(k) for its Fitbit and the companys new PPG (photoplethysmography) algorithm to identify atrial fibrillatio...

Promising Lebrikizumab Data in Atopic Dermatitis: Lilly

[ Price : $8.95]

Eli Lilly says new data on lebrikizumab show the therapy in combination with standard-of-care topical corticosteroids achieved at ...