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Accelerated Approval Pathway Possible for Emphysema Drug

[ Price : $8.95]

FDA tells Inhibrx that there is potential to pursue an accelerated approval for INBRX-101 for treating patients with emphysema due...

Rare Disease Endpoint Advancement Pilot

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FDA launches a Rare Disease Endpoint Advancement pilot program as called for in the PDUFA 7 reauthorization.

Flawless Beauty and Skin Selling Illegal Products: FDA

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FDA warns Ocean, NJ-based Flawless Beauty and Skin that it is illegally distributing imported medical devices used in skin care.

CGMP Violations at Sterling Pharmaceutical

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FDA warns Dupo, IL-based Sterling Pharmaceutical Services about CGMP and other violations in its production of finished drugs.

FDA Meets STAR Pilot Commitment

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FDA starts the Split Real Time Application Review pilot program called for in the PDUFA 7 reauthorization.

U.S. Govt Asked to Weigh in on Skinny Label Case

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The U.S. Supreme Court asks the government to weigh in on Tevas appeal of a court decision in a case involving a so-called skinny ...

CDRH Encourages Device eSubmissions Through Portal

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FDA says device makers can now send electronic copy (eCopy) or electronic Submission Template And Resource (eSTAR) premarket submi...

Accelerated Approval Transforms Precision Oncology: Study

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FDA and other researchers tout the benefits of the accelerated approval pathway in precision oncology.

510(k), De Novo, PMA Review Clock Guidances

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FDA publishes three guidances describing the effect on the review clock and goals of agency and industry actions in de novo, 510(k...

Fast Track for Calithera Bio Lung Cancer Drug

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FDA grants Calithera Biosciences a fast track designation for mTORC 1/2 inhibitor sapanisertib (CB-228) for treating certain adult...