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FDA Needs Help in Regulating Algorithms: Califf

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FDA commissioner Robert Califf says FDA needs to work within a community of organizations assessing and evaluating artificial inte...

DermaSensor AI Skin Cancer Detector Cleared

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FDA clears DermaSensor's real-time, skin cancer evaluation system.

FDA Extends Narcan Shelf Life

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FDA extends the shelf life of Emergent BioSolutions newly manufactured Narcan (naloxone HCl) 4 mg nasal spray products from three ...

Reschedule Marijuana to Schedule 3: FDA

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FDA recommends that the Drug Enforcement Administration down-classify marijuana from Schedule 1 to Schedule 3 under the Controlled...

Nurix Therapeutics Gets Fast Track Status

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FDA grants Nurix Therapeutics a fast track designation for NX-5948 for treating certain adult patients with relapsed or refractory...

Info Collection on New Dietary Ingredients

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Federal Register notice: FDA revises an information collection entitled Premarket Notification for a New Dietary Ingredient (NDI) ...

Multiple Violations at Dr. Joel Kaplan Inc.

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FDA warns San Diego, CA-based Dr. Joel Kaplan Inc. about multiple violations in its manufacturing and distribution of several devi...

Docs Dont Understand FDA Approval Process: Research

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A physician survey conducted by UCSF researchers finds many doctors dont understand how FDA approves new drugs and medical devices...

Hemogenyx Responds to Clinical Hold

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Hemogenyx Pharmaceuticals files its complete response to an FDA HEMO-CAR-T clinical hold in hopes of starting Phase 1 trials.

Clinical Trial Modernization and Innovation Meeting

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FDA publishes the summary of an October 2023 public meeting on continuing the Covid-19 lessons learned for modernization and innov...