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Manufacturing vs. Compounding Line Hard to Draw, FDA Told

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FDA is told by state representatives that the defining differences between compounding and manufacturing remain the major problem ...

Supplements Recalled Due to Undeclared Ingredients

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Performance Plus Marketing recalls Libigrow, Libigrow XXXtreme, Blue Diamond, Blue Diamond Platinum, Mojo Nights, Mojo Nights Supr...

Guidance on Certification for Medical Gases

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Federal Register Notice: FDA releases a draft guidance, Certification Process for Designated Medical Gases.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Axiobionics, Basic Organics, Leisure Products, and Prime Herbs Corp.

Quality System Violations in Wearable Therapy Production

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FDAs Detroit District Office warns Axiobionics about Quality System and other violations in its manufacturing of electrical stimul...

FDA Says Oregon IRB Failed to Protect Human Subjects

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FDA warns the Salem, Oregon, Hospital IRB about violations of the law and regulations that protect human research subjects.

FDA Approves Mylans Generic Qualaquin

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FDA approves a Mylan Pharmaceuticals ANDA for a generic version of Mutual Pharmaceutical Co.s antimalarial Qualaquin.

FDA Accepts Telemonitoring for Lisinopril MS Trial

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FDA approves a Phase 2a IND trial of lisinopril for treating multiple sclerosis using telemonitoring instead of most patient trial...

Group Says Hamburg Gave Inaccurate Testimony on Compounding

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Public Citizen says FDA commissioner Margaret Hamburg provided inaccurate testimony about pharmacy compounding last month during C...

FDA Clears Avinger Imaging Catheter

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FDA clears an Avinger 510(k) for its Ocelot PIXL imaging catheter with onboard imaging for crossing chronic total occlusions in pa...