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PhRMA Wants Changes to Platform Tech Designation

[ Price : $8.95]

PhRMA makes nine recommendations for changes to an FDA draft guidance on the platform technology designation program.

Correct Misleading AbbVie Study Description: Ali

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Ali Pharmaceutical asks FDA to require AbbVie to stop saying it is using Alis Armour Thyroid in a clinical trial since it is using...

Many Ideas to Approve FDA Regulation of AI: Article

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Politico explores the many ideas people have for improving FDFA regulation of artificial intelligence.

FDA Study Analyzes Provider View of Boxed Warnings

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CDER reports on research into how healthcare providers view and use Boxed Warnings when making treatment decisions for their patie...

Denali Aims for Early 2025 Hunter Syndrome BLA

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Denali Therapeutics plans to submit a BLA early next year that will seek accelerated approval for DNL310 (tividenofusp alfa) and i...

Guidance on BIMO Data Technical Specifications

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FDA releases a guidance entitled Bioresearch Monitoring Technical Conformance Guide Technical Specifications Document that provid...

Otsuka Pharmaceutical FDA-483 Released

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FDA releases the form FDA-483 with five observations from an inspection at the Otsuka Pharmaceutical second factory in Tokushima, ...

FDA Clears Embecta Disposable Insulin Patch Pump

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FDA clears an Embecta 510(k) for its Disposable Patch Pump for Insulin Delivery, intended for use by adults who require insulin to...

ADHD Digital Therapy Devices Put Into Class 2

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Federal Register notice: FDA classifies certain digital therapy devices for attention deficit hyperactivity disorder into Class 2.

Class 2 for Neuromuscular Tongue Muscle Stimulators

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Federal Register notice: FDA classifies neuromuscular tongue muscle stimulators and their use for reducing snoring and obstructive...