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Lawmakers Question FDA on Canadian Drug Importation

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Six Republican lawmakers urge FDA commissioner Robert Califf to update them about an ongoing delay to review Floridas proposed Can...

Comments on FDA Medical Queries

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Two stakeholders comment on an FDA workshop on advancing premarket safety analytics.

Amazon Distributing Misbranded, Unapproved Drugs: FDA

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FDA warns Amazon.com it is distributing unapproved new drugs.

Violations at Sovereign Pharmaceuticals

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FDA warns Fort Worth, TX-based Sovereign Pharmaceuticals about CGMP violations in its manufacturing and distribution of an unappro...

Comments on ICH Pediatric Extrapolation Guidance

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Two drug stakeholder associations raise questions and suggest changes to an International Council for Harmonization draft guidance...

Revised Expanded Access Q&A Guidance

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FDA issues an updated question-and-answer draft guidance on expanded access to investigational drugs for treatment use.

Dont Approve Some Tc-99m NDAs: Petition

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A citizen petition asks FDA not to approve any Technetium-99m product produced through neutron capture in a conventional generator...

CGMP Violations at Lupin Limited

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FDA warns Indias Lupin Limited about CGMP deviations in the production of active pharmaceutical ingredients.

Use of Expedited Drug Review Programs Increasing

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FDA researchers say industry use of the accelerated approval, breakthrough therapy, fast track, and priority review programs has i...

FDA Defers Action on Amicus BLA

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FDA says it is deferring action on an Amicus BLA for cipaglucosidase alfa as part of a treatment for Pompe disease until the agenc...