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FDA Revamping Inspection Planning System, Other Changes: Report

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A new FDA report on Covid-19 activities notes that the agency is initiating a new inspection planning system that will be more eff...

FDA Cites Sun Pharma Over GMP Violations

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A just-completed FDA inspection of Sun Pharmaceutical Industries Punjab, India manufacturing facility leads to a six-item Form FDA...

Cipla India Plant Receives FDA-483

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FDA sends India-based Cipla Ltd. a two-item Form FDA-483 after a recent inspection at its Madhya Pradesh, India manufacturing plan...

Pfizer Required to Conduct Paxlovid Covid Rebound Trial

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FDA revises a Pfizers emergency use authorization for Paxlovid (nirmatrelvir co-packaged with ritonavir) for treating mild-to-mode...

Visibly At-Home Vision Test Cleared

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FDA clears a Visibly 510(k) for its Visibly Digital Acuity Product (VDAP), an at-home digital vision testing platform for determin...

Info Collection on CDRH Appeals Processes

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Federal Register notice: FDA sends to OMB an information collection extension entitled Center for Devices and Radiological Health ...

False Claims Act Used in Off-Label Cases: Attorney

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Attorney Keeley McCarty warns medical device manufacturers that the government is pursuing False Claims Act cases against companie...

CDER Working on Pediatric Extrapolation Framework

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CDER researchers say they are developing a non-inferiority paradigm to assess exposure-response similarity between pediatric and a...

Medical Device Recalls Up in 2nd Quarter: Sedgwick

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The Sedgwick Recall Index says medical device recalls soared in the second quarter of 2022, while drug recalls remained level with...

Draft Guide on Contact Lens Care Labeling

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Federal Register notice: FDA makes available a draft guidance entitled Hydrogen Peroxide- Based Contact Lens Care Products: Consum...