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NC Learned Intermediary Law Covers Devices: Court

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A North Carolina federal judge says the states learned intermediary law applies to medical devices although the law only specifica...

Zafgen Reports Patient Death in Obesity Drug Trial

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Zafgen reports to FDA a patient death that occurred in its ongoing Phase 3 study of beloranib in Prader-Willi Syndrome, a rare gen...

Essure Patients Blitz Shurens In-box: Kill PMA, Resign

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An email campaign by over 100 injured Essure patients deluges CDRH director Jeffrey Shurens in-box, demanding that he revoke Essur...

Comments Reopened on PDUFA Reauthorization

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Federal Register Notice: FDA reopens the comment period on a notice of public meeting on the reauthorization of the Prescription D...

Quality Control Problems at InvaGen

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FDA says that InvaGen Pharmaceuticals is not following quality control responsibilities and procedures fully.

Shuren Wants Learning Medical Device Ecosystem

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CDRH director Jeffrey Shuren tells a conference that FDA wants to develop a new approach to medical device regulation that would p...

CGMP Violations in Unimark Remedies Inspection

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FDA warns Indias Unimark Remedies about significant current good manufacturing practice deviations in its manufacturing of active ...

Two UDI-Related Rules Finalized

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FDA says that two recently published final rules will help develop the infrastructure needed for widespread use of unique device i...

Draft Vector Guidance Out

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FDA issues a draft guidance with recommendations for IND sponsors on microbial vectors used for gene therapy.

Ancestry.com Talks With FDA on Genetic Test

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Ancestry.com says it is seeking FDA permission to use its DNA test to inform people about their health risks.