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GEs Shatterproof Bulk Package for Contrast Agent OKd

[ Price : $8.95]

FDA approves GE Healthcares shatterproof polymer +PLUSPAK Pharmacy Bulk Package for use with its macrocyclic gadolinium-based MRI ...

Comments on IND Communications with FDA

[ Price : $8.95]

Three drug industry stakeholders give FDA feedback on its public meeting on an independent assessment of FDA-sponsor IND communica...

Trust Down for FDA, Drug Companies: Poll

[ Price : $8.95]

Axios/Ipsos poll respondents say they have little faith in FDA or the drug industry to be looking out for the publics interests.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Kalchem International, Mayons Pharmaceuticals and Silkprousa.

False, Misleading Claims in Sprout Addyi Radio Ad: OPDP

[ Price : $8.95]

FDA warns Sprout Pharmaceuticals about a violative radio ad for Addyi, indicated for women with low sexual desire.

CGMP Issues at Kalchem

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FDA warns Kalchem International about new and repeated CGMP violations and deviations in its production of finished drugs and APIs...

Vertex Wins Priority Review Voucher

[ Price : $8.95]

Federal Register notice: FDA issues a priority review voucher to Vertex Pharmaceutical for Trikafta (elexacaftor/tezacaftor/ivacaf...

Final Guide on Device Consensus Standards

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Federal Register notice: FDA makes available a final guidance entitled Recognition and Withdrawal of Voluntary Consensus Standards...

Information Collections Approved by OMB

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Federal Register notice: FDA posts a list of information collections that have been approved by OMB under the Paperwork Reduction ...

Drug Labeling Geriatric Information Guidance

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FDA publishes a draft guidance with updated recommendations for including geriatric information in the labeling for prescription h...