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Pfizer Petitions FDA for Guidance on Biosimilar Communications

[ Price : $8.95]

Pfizer petitions FDA to issue a guidance document to clarify appropriate sponsor communications about the nature and properties of...

Pharmaceutical Quality Site Visit Program

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Federal Register notice: CDER announces the Fiscal Year 2019 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learni...

Plasma Lyte Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Plasma Lyte M And Dextrose 5% and Plasma Lyte and Dextrose 5% were not withdrawn for...

Guide on Hematologic Malignancy and Oncologic Drug Trials

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Federal Register notice: FDA makes available a draft guidance entitled Hematologic Malignancy and Oncologic Disease: Consideration...

Appeals Court Reverses GSK $3 Million Liability Suit

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The U.S. Court of Appeals for the Seventh Circuit reverses a lower court decision and $3 million verdict in a product liability th...

Ortho Dermatologics Tretinoin Lotion Approved

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FDA approves an Ortho Dermatologics NDA for Altreno (tretinoin 0.05%) lotion, indicated for the topical treatment of acne vulgaris...

Info Collection Extension for User Fee Cover Sheet

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Federal Register notice: FDA seeks comments on an information collection extension entitled Prescription Drug User Fee Cover Sheet...

DTC Ad Drug Pricing Amendment Passes Senate

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The Senate passes a bipartisan amendment introduced by Sens. Chuck Grassley (R-IA) and Dick Durbin (D-IL) requiring pharmaceutical...

Dthera Sciences Breakthrough Status for Alzheimers Device

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FDA grants Dthera Sciences a breakthrough device designation, for its Alzheimers treatment, DTHR-ALZ.

Trial Inclusion, Exclusion Workshop Report

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FDA releases a report summarizing its 4/16 public workshop on clinical trial inclusion and exclusion.