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Human Drugs

Norwich Sues FDA Over Rifaximin ANDA

Norwich Pharmaceuticals asks the DC federal court to order FDA to grant final approval to the companys amended ANDA for generic rifaximin to treat irr...

Human Drugs

PhRMA Agrees with Discontinuance Recommendations

PhRMA says it generally agrees with recommendations in an FDA draft guidance on notification of a permanent discontinuance or interruption in drug man...

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Human Drugs

FDAers Assess Frontline Renal Cancer Treatments

CDER and Oncology Center of Excellence researchers say a pooled analysis showed the frontline immune-oncology/tyrosine kinase inhibitor combination th...

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Human Drugs

Sun Pharma India Facility on Import Alert

FDA issues an import alert on drug products manufactured by Sun Pharmaceutical Industries in Gujrat, India due to significant GMP violations documente...

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FDA General

FDA Struggles to Recruit in Wake of Retirements

FDA chief of staff Julie Tierney says the agency is experiencing a larger-than-normal exodus of retiring employees now that the Covid-19 public health...

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Medical Devices

Abiomed Recalls Impella Heart Pump

Abiomed recalls its Impella 5.5 with SmartAssist System after receiving complaints about purge fluid leaking from the devices purge sidearm.

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Medical Devices

FDA on Pneumatic Tourniquet Cuff Shortage

FDA issues a Dear Doctor letter about supply constraints involving non-sterile, single-use pneumatic tourniquet cuffs in the U.S.

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Human Drugs

FDA Lifts Hold on Foghorn Leukemia Drug

FDA removes a partial clinical hold against Foghorn Therapeutics Phase 1 monotherapy dose escalation study of FHD-286 in acute myelogenous leukemia an...

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Medical Devices

Draeger Recalls Ventilator Sets/Tubing

Draeger Medical recalls its ventilator set, tubing and support (with harness) because glued connections on the breathing circuit can become loose.

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Human Drugs

Intas Pharma on Import Alert After Inspection

FDA places an import alert on drug products manufactured by Intas Pharmaceuticals in Ahmedabad, Gujarat, India due to significant GMP violations docum...