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Alcon Recalls Systane Ultra PF Eye Drops

[ Price : $8.95]

FDA says Alcon recalled one lot of Systane Ultra PF eye drops due to potential fungal contamination.

FDA OKs Arrays Braftovi for Some Cancers

[ Price : $8.95]

FDA approves Array BioPharmas Braftovi to treat some patients with metastatic colorectal cancer with a specific mutation.

Ionis Spinraza Approved by FDA for SMA

[ Price : $8.95]

FDA approves Ionis Spinraza as the first drug approved to treat children and adults with spinal muscular atrophy.

Guide on Device Supply Interruption Notifications

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FDA posts a final guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under...

Guide on Seeing if Confirmatory Study Underway

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FDA issues a draft guidance entitled Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Under...

Inogen Airway Clearance Device Cleared

[ Price : $8.95]

FDA clears an Inogen 510(k) for the Simeox 200 Airway Clearance Device.

Bhargava Phytolab CGMP Violations

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FDA warns Indias Bhargava Phytolab about CGMP issues in its manufacturing of finished drugs and active pharmaceutical ingredients....

FDA Wants Labeling Changes for Buprenorphine

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FDA recommends that companies making transmucosal buprenorphine drugs indicated to treat opioid dependence revise the labeling to ...

Global Unique Device ID Database Guidance

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FDA publishes an updated Global Unique Device Identification Database guidance.

CGMP Violations in Micro Orgo Chem Inspection

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FDA warns Indias Micro Orgo Chem about CGMP deviations in its production of active pharmaceutical ingredients.