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FDA Grants, Denies Draize Test Petition

[ Price : $8.95]

FDA grants a Center for Responsible Science petition to the extent that the agency no longer requires or recommends Draize dermal ...

AdvaMed on Metallic Coatings Characterization

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AdvaMed gives FDA a 14-page table with 44 suggested edits to a draft guidance on the characterization of metallic coatings and/or ...

Safety Labeling Changes for Fluorouracil Injection

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FDA approves safety labeling changes for fluorouracil injection products when used in patients with dihydropyrimidine dehydrogenas...

Vyaire Recalls AirLife Resuscitators

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Vyaire Medical recalls certain AirLife Manual Resuscitators due to a manufacturing defect.

Hearing Challenges FDA Rule on LDTs

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A House Energy and Commerce Health Subcommittee hearing discusses the need to legislatively reform FDAs oversight of laboratory-de...

Phase 3 Keytruda Miss in Lung Cancer

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Merck says its Phase 3 KEYLYNK-006 trial evaluating Keytruda (pembrolizumab) in combination with maintenance Lynparza (olaparib) d...

Abiomed Recalls Impella Blood Pumps

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Abiomed recalls its Impella Left Sided Blood Pumps because the pump catheter may slice the hearts left ventricle wall during proce...

Elixir Gets Breakthrough for DynamX BTK

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FDA grants Elixir Medical a breakthrough device designation for its DynamX BTK System, an adaptive implant for use in treating nar...

Check Key Info in Informed Consent

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Two SheppardMullin attorneys analyze a recent FDA draft guidance on informed consent and suggest steps that clinical trial sponsor...

Non-Interventional Studies Guidance

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FDA publishes a draft guidance on using non-interventional studies for drug and biological products to develop real-world evidence...