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AMA Backs Some Canadian Drug Imports

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The American Medical Association adopts policy to support personal importation of prescription drugs from licensed Canadian brick-...

FDA Public Meetings on e-Adverse Event Reports

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Federal Register notice: FDA announces three public meetings entitled Electronic Submission of Adverse Event Reports to FDA Advers...

Proposal to Allow Informed Consent Exceptions

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Federal Register proposed rule: FDA proposes to amend its regulations to implement a provision of the 21st Century Cures Act that ...

Oscor Expands TB Pacing Lead Recall

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FDA says Oscor has expanded the time period covered in its recall of TB pacing leads to ensure proper disposition of expired units...

Breakthrough Designation for Seattle Genetics Adcetris

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FDA grants Seattle Genetics a breakthrough therapy designation for Adcetris (brentuximab vedotin) for previously untreated systemi...

FDA Says GE Millennium System Recall Class 1

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FDA says a GE Healthcare recall of Millennium nuclear medicine imaging systems is Class 1.

More FDA Biosimilar Support Needed: Novartis

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Novartis says FDA and HHS could do more to counter false information about and promote increased use of biosimilars and interchang...

Using Social Media for Drug Use Trends

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CDER Office of Communications associate director Paula Rausch describes how FDA monitors social media and online conversations as ...

Panel Recommends Approval of SpecGx Oxycodone Formulation

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Two FDA advisory committees vote in a joint meeting to recommend approval of Mallinckrodt subsidiary SpecGxs investigative abuse-d...

PharmaCyte IND Safety Report for Pancreatic Cancer Drug

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PharmaCyte Biotech completes an FDA-required formal report on safety studies using a pig model that were undertaken before getting...