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FDA Flags Abiomed, Oscor Correction of Impella Catheter Introducers

[ Price : $8.95]

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...

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...

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...

Moderna Wins Approval for mRNA Flu Vaccine

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FDA approves a Moderna BLA for mFLUSIVA (mRNA-1010), a new influenza vaccine for use in all adults 50 years and older.

FDA Signals Increased Scrutiny of Unapproved Animal-Derived Thyroid Drugs

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FDA signals that increased regulatory oversight might be on the horizon for unapproved animal-derived thyroid medications, which a...

Surge In FDA Drug Warning Letters Shows Structural Problem: Consultant

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Krieger Scientific founder Joseph Morwald says a surge in FDA drug Warning Letters is driven by an industry systemic problem that ...