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FDA Withdraws 8 Elanco NADAs

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Federal Register Notice: FDA withdraws approval of eight Elanco Animal Health new animal drug regulations.

FDA Draft Guidance on Risperdal Bioequivalence Studies

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FDA posts a draft guidance on Bioequivalence Recommendations for Risperidone that outlines recommended bioequivalence testing for ...

Cook Medical Class 1 Recall of Roadrunner Wire Guides

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Cook Medical begins a Class 1 recall of its Roadrunner Uniglide Hydrophilic Wire Guide due to potential coating contamination with...

Mylan to Launch EpiPen Authorized Generic to Curb Criticism

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Faced with mounting criticism over its costly EpiPen Auto-Injector (epinephrine injection), Mylan now says it will launch an autho...

Impax Recalls 1 Lot of Lamotrigine Due to Packaging Error

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Impax Laboratories recalls one lot of lamotrigine orally disintegrating tablets 200 mg (Lot # 502240) due to a packaging error.

Hybrid Pharma Cited in 8-page Form 483 After Inspection

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FDA cites Hybrid Pharma (Deerfield Beach, FL) in an eight-page Form-483 after a July inspection found that the firm had inadequate...

FDA Amends Animal Drug Regs to Post May/June Approvals

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Federal Register Final rule: FDA amends the animal drug regulations to reflect NADA and ANADA approvals, sponsor changes, and volu...

Seqirus Afluria Quadrivalent Flu Vaccine Approved

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FDA approves a Seqirus BLA for Afluria Quadrivalent (influenza vaccine) for use in those 18 years of age and older for active immu...

CDRH Review Consistency/Predictability Big Item in Next User Fee Cycle

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CDRH plans to improve medical device review consistency and predictability during the next user fee cycle (FY 2018-2022) through e...

Comments Sought on Import Trade Communication

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Federal Register Notice: FDA seeks comments on a collection of information on FDAs Import Trade Auxiliary Communication System.