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Human Drugs

Organon Wants Generic Nexplanon Restrictions

Organon asks FDA to put restrictions on ANDA applications citing Organons Nexplanon as the reference-listed drug.

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Human Drugs

4 Observations in Medi-Fare Inspection

FDA releases the form FDA-483 with four observations from an inspection at Medi-Fare, a Blacksburg, SC, outsourcing facility.

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Human Drugs

FDA Grants, Denies Draize Test Petition

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

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Medical Devices

AdvaMed on Metallic Coatings Characterization

AdvaMed gives FDA a 14-page table with 44 suggested edits to a draft guidance on the characterization of metallic coatings and/or calcium phosphate co...

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Human Drugs

Safety Labeling Changes for Fluorouracil Injection

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

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Medical Devices

Vyaire Recalls AirLife Resuscitators

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

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Medical Devices

Hearing Challenges FDA Rule on LDTs

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

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Human Drugs

Phase 3 Keytruda Miss in Lung Cancer

Merck says its Phase 3 KEYLYNK-006 trial evaluating Keytruda (pembrolizumab) in combination with maintenance Lynparza (olaparib) did not meet its prim...

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Human Drugs

Abiomed Recalls Impella Blood Pumps

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

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Medical Devices

Elixir Gets Breakthrough for DynamX BTK

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