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Smiths Recalls ParaPAC Ventilators

[ Price : $8.95]

Smiths Medical recalls (Class 1) its ParaPAC plus P300 and P310 ventilators due to the possibility that patient outlet connectors ...

Vanda Hits FDA for Rejecting Tradipitant

[ Price : $8.95]

Vanda criticizes FDA for failing to approve its NDA for tradipitant to treat gastroparesis.

Panel to Discuss Seasonal and Avian Flu Preparedness

[ Price : $8.95]

Federal Register notice: FDA announces a 10/10 Vaccines and Related Biological Products Advisory Committee meeting to discuss and ...

Contaminated Atovaquone Recalled by Bionpharma

[ Price : $8.95]

Bionpharma recalls (Class 1) a single Batch (#2310083) of atovaquone oral suspension due to contamination with Cohnella bacteria.

Medical Device Biocompatibility Guidance

[ Price : $8.95]

FDA publishes a draft guidance with recommended chemical analyses for medical device biocompatibility assessment.

Device User Fee Cover Sheet Info Collections

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Federal Register notice: FDA submits to OMB information collection revisions entitled Medical Device User Fee Cover Sheet, Form FD...

RFK Jr. to Recommend Trump Health Agency Heads?

[ Price : $8.95]

Mainstream health gadfly Robert K. Kennedy, Jr., says he has been asked by Donald Trump to be heavily involved in choosing people ...

CDER Biosim. Interchangeability Change Explained

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CDER director Patrizia Cavazzoni and Office of Therapeutic Biologics and Biosimilars director Sarah Yim say a revised FDA guidance...

Elanco Gets Anti-Itch Zenrelia Approved for Dogs

[ Price : $8.95]

FDA approves Elanco Animal Healths Zenrelia (ilunocitinib tablets), a once-daily oral JAK inhibitor for controlling itching associ...

FDA Hits Spanish Drug Facility with 483

[ Price : $8.95]

FDA cites Laboratorios Farmaceuticos Rovi in a four-item Form FDA-484 after inspecting the companys Madrid, Spain manufacturing fa...