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Ways to Improve Pediatric Device Development: AdvaMed

[ Price : $8.95]

AdvaMed gives FDA recommendations for ways to reduce risk in pediatric medical device development.

Olympus 510(k) for EZ Shot 3 Plus Needle Cleared

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FDA clears an Olympus 510(k) for its EZ Shot 3 Plus 25 G needle as well as an expanded indication for the EZ Shot 3 Plus product l...

Finalize Patient Data Collection Guidance: PhRMA

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PhRMA calls on FDA to finalize a draft guidance on collecting patient experience data in a timely manner so the guidance may help ...

Immediate-Release Opioids Now Under REMS

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FDA approves a new opioid analgesic REMS that now covers immediate-release products and expands provider education requirements.

CBER Planning 16 Guidances for 2018

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CBER says it expects to publish 16 guidances under two categories during calendar year 2018.

Quality System Violations at ITG-Medev

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FDA warns ITG-Medev about Quality System violations in its manufacturing of Omiderm wound dressings.

CGMP Violations at Jabones y Productos Especializados

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FDA warns Mexicos Jabones Y Productos Especializados about CGMP violations in its production of finished pharmaceuticals.

Meditech Spine Cure Opel-C Plate System Cleared

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FDA clears a Meditech Spine 510(k) for its Cure Opel-C Plate System, an add-on technology to its already cleared Cure ACP System a...

Comments Sought on Pediatric Safety Reviews

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Federal Register notice: FDA establishes a public docket to collect comments related to the post-marketing, pediatric-focused safe...

Panel to Review CV Risk Assessments with Diabetes Drugs

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Federal Register notice: FDA announces a 10/24-25 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss the age...