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ITM Receives FDA Complete Response Letter for Radiopharmaceutical

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FDA sends ITM Isotope Technologies Munich SE a Complete Response Letter (CRL) for its investigational radiopharmaceutical for gast...

FDA Flags Abiomed, Oscor Correction of Impella Catheter Introducers

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Abiomed and manufacturing partner Oscor issue a correction (Class 1 recall) for certain catheter introducers used with Impella hea...

Ibrahim Appointed CDER Deputy Center Director

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FDA appoints Sarah Ibrahim as CDER deputy center director for Regulatory Programs, a role she has been serving in an acting capaci...

Panel to Review Next-Gen Cancer Detector Test

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FDA's announces a 9/23 advisory committee meeting to vote on a Grail PMA for the Galleri test and its use in the early detection o...

Primus Resubmits Generic Impoyz Petition

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Primus petitions FDA to address substantive issues about generic forms of its Impoyz psoriasis drug that were first raised by Enco...

FDA Cites Emcure Pharmaceuticals' India Pant Over GMP Issues

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FDA cites Emcure Pharmaceuticals' sterile injectable manufacturing facility in Ahmedabad, India, for multiple GMP deficiencies fol...

Trump Administration Weighs Executive Order on Autism, Vaccines

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The Trump administration considers an executive order addressing vaccines and autism as soon as next week.

Senators Introduce Prescription Information Modernization Act

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Senators Jim Banks (R-IN) ) and Cory Booker (D-NJ) introduce the bipartisan Prescription Information Modernization Act to allow dr...

FDA Launches DSCSA Small Dispenser Assessment

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FDA calls on small drug dispensers with no more than 25 employees to complete an assessment so the agency can evaluate the dispens...

Reps. Want FDA to Address Estrogen Patch Shortages

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Eight House Democrats ask FDA acting commissioner Kyle Diamantas what the agency is doing and can do to ease a growing shortage of...