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Aurobindo Inspection Yields 2 Observations

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FDA releases a FDA-483 issued to Aurobindo Pharma following an inspection at its Hyderabad drug manufacturing facility.

Is FDA Heading for A Consistent Fat Stem Cell Approach?

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An online blog post looks at possible ways FDA could expand its approach to stem cell clinics marketing products the agency consid...

Orphan Status for Cascadian Colorectal Cancer Therapy

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FDA grants Cascadian Therapeutics an orphan drug designation to tucatinib for treating HER2-positive metastatic colorectal cancer.

FDA Clears Fotona Laser System for Tattoos, Lesions

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FDA clears a Fotona 510(k) for its new StarWalker MaQX Q-Switched laser system for treating tattoos, pigmented and vascular lesion...

Hologic Laser Treatment Cleared on Double Chins

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FDA clears a Hologic 510(k) for the body laser contouring product SculpSure to treat a double chin (submental area).

Mammography Quality Advisory Committee Renewed for 2 Years

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Federal Register notice: FDA announces the renewal of the National Mammography Quality Assurance Advisory Committee.

Steps to Close the Efficacy-Effectiveness Gap

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A Health Affairs blog post looks at ways to close the gap between results seen in randomized clinical trials and those obtained fr...

Allergan Gets Refuse-to-File on Schizophrenia Drug

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FDA issues Allergan a refuse-to-file letter on a supplemental NDA for Vraylar (cariprazine) for treating negative symptoms associa...

FDA Approves Abbotts Continuous Glucose Monitor

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FDA approves an Abbott Diabetes Care PMA for the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose mon...

3 Dr. Reddys Inspection Observations

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FDA releases a FDA-483 issued to a Dr. Reddys drug manufacturing facility in the UK.