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FDA Will Allow Continued Iclusig Use Under Emergency IND

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FDA says healthcare professionals may continue to treat some patients with Iclusig under an emergency IND.

FDA Recommends Steps to Counter Heparin Risk

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FDA gives healthcare professionals timing recommendations for placing and removing spinal catheters in patients taking low molecul...

PhRMA, Genetic Alliance Working on Patient-focused Drugs

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PhRMA announces a joint program with the Genetic Alliance to use crowd-sourced technology to learn patients experiences with three...

RTI to Research Drug Ads for FDA

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FDA awards a $4 million contract to RTI International for five studies of various aspects of consumer response to DTC drug ads.

Moban Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Moban tablets and capsules were not withdrawn from sale for reasons of safety or effe...

Guidance on Developing Tuberculosis Drugs

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Federal Register Notice: FDA releases a guidance, Pulmonary Tuberculosis: Developing Drugs For Treatment.

Public Meeting on Sickle-Cell Disease

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Federal Register Notice: FDA plans a public meeting 2/7/14 on patient-focused drug development for sickle cell disease.

Opportunity for Hearing on Withdrawal of 14 NDAs

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Federal Register Notice: FDA announces an opportunity to request a hearing on a proposal to withdraw approval of 14 NDAs.

Baylis TorFlex Sheath Kit Recall is Class 1

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FDA says a Baylis Medical recall of its TorFlex transseptal guiding sheath kits is Class 1.

Medical Device Trial Design Guidance Out

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CDRH issues a guidance on considerations for study design in medical device pivotal studies.