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4 Repeat CGMP Violations at Canadas Innocore

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FDA warns Innocore Sales & Marketing in Woodstock, Ontario, Canada, about CGMP violations in its production of finished drugs.

OND Deputy Named Permanent Director

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FDA names acting Office of New Drugs (OND) director Mary Tran Thanh-Hai as the new OND director, replacing previous head Peter Ste...

Is FDA Lengthening Warning Letter Response Time?

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Three Hyman, Phelps & McNamara attorneys notice that FDA has provided a 30-day response time instead of the usual 15 days for two ...

Dr. Reddys Hit with 7-Item FDA-483

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FDA posts a seven-item Form FDA-483 after inspecting Dr. Reddys Mirfield, West Yorkshire, UK, active pharmaceutical ingredient man...

Intellia Pauses Gene Therapy Phase 3 Trials

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Intellia Therapeutics pauses two Phase 3 trials of nex-z, a CRISPR-based therapy for transthyretin amyloidosis with cardiomyopathy...

Senate Letter Presses HHS on Foreign Generic Drugs

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A Senate Committee demands answers from HHS on what they describe as serious national security and public health risks tied to Ame...

BridgeBio Plans NDA for Muscular Dystrophy Therapy

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BridgeBio reports positive Phase 3 data for BBP-418 in limb-girdle muscular dystrophy patients as it plans an NDA filing in second...

Guide on Device Quality Management Submission Info

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FDA releases a draft guidance outlining recommendations for medical device manufacturers on the type of Quality Management System ...

Hetero Labs India Warehouse Cited After Inspection

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FDA posts a six-item Form FDA-483 after inspecting Hetero Labs Vishakapatnam, India, warehouse last month.

FDA Expands Mercks Winrevair Label

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FDA approves an expanded indication for Mercks pulmonary arterial hypertension therapy Winrevair (sotatercept-csrk), clearing the ...