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FDA OKs Glaukos Intraocular Pressure Drug Implant

[ Price : $8.95]

FDA approves a Glaukos Corp. NDA for iDOSE TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for reduc...

2 Imbruvica Accelerated Approvals Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of the indications for mantle cell lymphoma and marginal zone lymphoma for Pharmac...

DTC Survey Examines Quantitative Claims

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection proposal entitled A Survey on Quantitative Claims in Direct-to...

FDA Updates Breast Implant Safety Info

[ Price : $8.95]

FDA updates its Risks and Complications of Breast Implants Web page that clarifies information about implant removal and adds ultr...

Guide on Priority Zoonotic Animal Drugs

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FDA posts a draft guidance entitled Priority Zoonotic Animal Drug (PZAD) Designation and Review Process.

Moderna Inspection Cites GMP Issues: Report

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FDA investigators cite five GMP issues during a September inspection at Modernas primary facility in Norwood, MA, according to a R...

FDA Warns Makers of Illegal Animal Antimicrobials

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FDA sends Warning Letters to nine manufacturers and distributors of misbranded unapproved animal antimicrobial drugs.

FDA in 3 More Collaborative Communities

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FDA says it is participating in three new medical device collaborative communities.

House Committee Threatens FDA Subpoena

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House Energy and Commerce Committee Republicans threaten to subpoena FDA if it continues to not produce foreign drug inspection in...

Abbott PMA for GLP Systems Track

[ Price : $8.95]

FDA approves an Abbott PMA for its automated GLP systems Track, which is intended to support high-volume laboratory needs and maxi...