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Senators Introduce Prescription Information Modernization Act

[ Price : $8.95]

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 ...

AdvaMed Strongly Backs MDUFA 6 Agreement

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AdvaMed voices strong public support for the MDUFA 6 commitment reached with FDA.

FDA Accelerated Approval for Replimune Melanoma Therapy

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FDA grants acelerated approval to Replimune for its Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic vi...

Device Regulators Guide on Change Control Plans for Device Software

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The International Medical Device Regulators Forum releases a final document outlining global principles for Predetermined Change C...