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Review Process Strains FDA-Industry Relations

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PricewaterhouseCoopers says relations between industry and FDA over regulatory review processes are becoming strained.

FDA Grants 'Orphan' Status for Radiation Exposure Drug

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FDA grants Cleveland BioLabs an orphan drug designation for CBLB502, a drug under development for treating radiation exposure.

CDER Affirms Ranbaxy Generic Aricept Exclusivity

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CDER says that Ranbaxy is entitled to 180-day marketing exclusivity for generic Aricept.

Concerns Raised About ABSSSI Draft Guidance

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PhRMA raises concerns with two aspects of an FDA draft guidance on developing drugs to treat acute bacterial skin and skin structu...

Align Technology Warned on MDR Violations

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FDAs San Francisco District Office warns Align Technology of Medical Device Reporting violations associated with its Invisalign Sy...

Class 1 Recall for B. Braun addEASE Binary Connectors

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FDA posts a 6/28 urgent Class 1 recall of B. Brauns fluid transfer addEASE binary connector because stopper fragments may enter a ...

Panel to Discuss Electroconvulsive Therapy Devices

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Federal Register Notice: FDAs Neurological Devices Panel will meet 1/27-28/11 to discuss reclassifying electroconvulsive therapy d...

CDER Revises ANDA Impurities Guidance

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FDA releases an updated guidance document that provides recommendations on the chemistry, manufacturing, and controls information ...

FDA Says McNeil Quality Problems Continue

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An FDA inspection finds continuing and repeat quality violations at a McNeil Puerto Rico manufacturing facility.

FDA Issues 2 Bacterial-Product Guidances

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FDA issues two guidances on aspects of antibacterial drugs.