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Panel Recommends Against Mercury-containing Amalgam

[ Price : $8.95]

FDAs Immunology Devices Panel of the Medical Devices Advisory Committee recommends that FDA should require dentists to move away f...

Cerapedics PMA Supplement OKd for Bone Graft

[ Price : $8.95]

FDA approves a Cerapedics PMA supplement for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion proce...

CDRH Patient and Caregiver Connection Program

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CDRH sets up a Patient and Caregiver Connection program to obtain feedback from these stakeholders on their experiences living wit...

Contact Lens for Pediatric Myopia Slowing Approved

[ Price : $8.95]

FDA approves CooperVisions MiSight, the first contact lens indicated to slow the progression of myopia in children between the age...

Levo Therapeutics Fast Track for Prader-Willi Drug

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FDA grants Levo Therapeutics a fast track designation for LV-101 (intranasal carbetocin) for treating Prader-Willi syndrome.

25th Approved Biosimilar Goes to Pfizers Abrilada

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FDA hits a milestone with the approval of Pfizers Abrilada (adalimumab - afzb), a biosimilar to AbbVies Humira, which is the 25th ...

Guidance on Smallpox Drug Development

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FDA issues a final guidance entitled Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.

Proposal to Withdraw 4 NDAs

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Federal Register notice: FDA proposes to withdraw approval of four NDAs from multiple NDA holders because they have repeatedly fai...

OTC Drugs Panel Charter Renewal

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Federal Register notice: FDA announces the renewal of the Nonprescription Drugs Advisory Committee for an additional two years.

Info Collection on Device Q-Submission Program

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Federal Register notice: FDA sends to OMB an information collection extension for Q-Submission Program for Medical Devices.