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Transcept Resubmits Intermezzo NDA

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Transcept resubmits its Intermezzo NDA to FDA following a meeting with FDA staff.

CDER Chemist Faces New Charges

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CDER chemist Chang Liang has been charged with one count each of insider trading, making false statements, and aiding and abetting...

FDA Clears Child Face Mask

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FDA clears a Kimberly-Clark child face mask to help reduce spread of airborne pathogens.

Chelsea Therapeutics Submits NDA for Northera

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Chelsea Therapeutics submits an NDA to FDA for Northera for treating neurogenic orthostatic hypotension.

FDA, Hill Under Consent Decree

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FDA says it has entered into a consent decree with Hill Dermaceuticals, Hill Labs, and two individuals over CGMP and other problem...

FDA Classifies Pathway Genetic Kit as Class I

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FDA classifies Pathway Genomics genetic testing kit, blocked last year from OTC sale at Walgreens drug stores, as a Class 1 exempt...

CDRH Remaking IDE Process: Maisel

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CDRH chief scientist William Maisel says the Center is planning to release three guidance documents this fall to help improve its ...

Withdraw Classification Draft Guidance: WLF

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Washington Legal Foundation says that FDA should withdraw its draft guidance on product classification or submit it for notice and...

HHS Media Guidelines an Unconstitutional Power Grab

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FDA Webview editor Jim Dickinson comments on new HHS-wide restrictions on communications between the departments employees and mem...

Quality Problems Found in Sichuan APIs

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FDA warns Sichuan Pharmaceutical of CGMP deviations at its Chinese API manufacturing facility.