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FDA Says Industry Meets Postmarketing Study Timelines

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FDA says that its poor record-keeping is to blame for not realizing that 80% of required post-marketing drug studies are on schedu...

Be Suspicious of New Diseases in DTC Ads: Weil

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Integrative medicine physician Andrew Weil says that consumers should be on guard against drug company efforts to invent new disea...

FDA Balanced Efficacy and Risk in Prasugrel Approval: Unger

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FDAer Ellis Unger reviews the agencys deliberations in approving prasugrel with several risk mitigation strategies.

FDA Delayed Lead-in-Lipstick Study 2 Years: Advocacy Group

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Hard on the heels of complaints that it hid dental amalgams mercury content from consumers, the Campaign for Safe Cosmetics says t...

Better Predictability Seen Coming to FDA

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FDA affairs analyst Steven Grossman says changes being brought by commissioner Margaret Hamburg and principal deputy Joshua Sharfs...

FDA Approves Medas Astepro for Allergic Rhinitis

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FDA approves Medas Astepro nasal antihistamine spray for treating seasonal and perennial allergic rhinitis.

Advisors Recommend Onrigin Trial

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Members of FDAs Oncologic Drugs Advisory Committee recommend that Vion be required to conduct a clinical trial before FDA consider...

Teva Stops Vet Drug Production

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Teva Animal Health closes its St. Joseph, MO, veterinary drug manufacturing facility under terms of a consent decree with FDA.

FDA Fast Track for ALS Drug

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FDA grants a fast-track designation to Knopp Neurosciences for KNS-760704, a compound used to treat amyotrophic lateral sclerosis ...

Advisors Recommend Romidepsin Approval

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FDAs Oncologic Drugs Advisory Committee recommends approval of Gloucester Pharmaceuticals romidepsin for treating cutaneous T-cell...