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Suggestions for FDA Adaptive Design Draft Guidance

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Stakeholders praise an FDA draft guidance on adaptive designs for drug and biologic trials and offer some recommendations for impr...

FDA Efforts on Drug Shortages Told at Policy Conference

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Several CDER experts report to a drug shortage conference on agency efforts to date to take a fresh look at the drivers of drug sh...

Joint Panels to Review Uloric Cardiovascular Safety

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Federal Register notice: FDA announces a 1/11/2019 joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Mana...

Dual 510(k), CLIA Waiver Application Guidance

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FDA issues a draft guidance to assist manufacturers in using the Dual 510(k) and CLIA Waiver by Application pathway.

User Fee Meeting on eSubmission Data Standards

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Federal Register notice: FDA announces a 4/10/2019 public meeting entitled Prescription Drug User Fee Act of 2017; Electronic Subm...

FDA Issues 63 Product-Specific Guidances for Generics

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FDA issues 63 new and revised product-specific guidances to promote development of generic drugs.

Objectionable Study Conditions at Corona Doctors Medical

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FDA warns Corona Doctors Medical Clinics about objectionable conditions in its conduct of a clinical investigation.

Ortho Gains Expanded Use for HIV Combo Test

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FDA approves an Ortho Clinical Diagnostics expanded indication for its Vitros Immunodiagnostic Products HIV Combo Reagent Pack and...

gammaCore Nerve Stimilator Expanded for Headaches

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FDA clears an electroCore 510(k) for an expanded label for gammaCore vagus nerve stimulator therapy for adjunctive use for prevent...

CLIA Waiver Applications Update Guidance

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FDA issues a draft guidance to update Section V of a 2008 CLIA Waiver guidance.