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Impax Recalls 1 Lot of Lamotrigine Due to Packaging Error

[ Price : $8.95]

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.

Guidance on Systemic Antibacterial Drugs Data

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Federal Register Notice: FDA releases a guidance: Microbiology Data for Systemic Antibacterial Drugs Development, Analysis, and P...

Illinois Sues Insys Therapeutics Over Off-label Marketing

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Illinois attorney general Lisa Madigan files a lawsuit against Insys Therapeutics for deceptively marketing and selling Subsys, a ...

FDA Fast Track for Mallinckrodt Duchenne Drug

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FDA grants Mallinckrodt a fast track designation for Synacthen Depot (tetracosactide) and its use in treating Duchenne muscular dy...

FDA Orphan Designation for Biotie Therapies Liver Drug

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FDA grants Biotie Therapies an orphan drug designation for its BTT1023 drug candidate for treating primary sclerosing cholangitis,...