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Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company PetNet Solutions.

HeartVista AI-assisted MRI Software Cleared

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FDA clears a HeartVista 510(k) to use its artificial intelligence-assisted One Click MRI acquisition software for cardiac exams.

Info Collection Extension for CLIA Categorizations

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Federal Register notice: FDA sends to OMB an information collection extension entitled Administrative Procedures for Clinical Labo...

Heron NDA Resubmission for Post-Op Pain Drug

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FDA accepts for review a Heron Therapeutics NDA resubmission for HTX-011, an investigational agent for managing postoperative pain...

OMB Clears 10 Information Collections

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Federal Register notice: FDA posts a list of FDA information collections recently approved by OMB.

FDA Alert Update on Endovascular Grafts

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FDA updates a 2018 safety alert about Endologixs AFX endovascular graft systems used in treating abdominal aortic aneurysms and th...

Public Meeting on Pediatric Study Requirements

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Federal Register notice: FDA announces an 11/21 public meeting seeking input on a report to Congress about pediatric study require...

Info Collection on Drug Maker Emergency Plans

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Federal Register notice: FDA seeks comments on an information collection extension entitled Planning for the Effects of High Absen...

Type 5 DMFs for Drug-led Combo Product Guide

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FDA posts a draft guidance on Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics or Sof...

FDA Fact Sheet on Device Consensus Standards Pilot

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FDA releases a fact sheet to explain its Accreditation Scheme For Conformity Assessment (ASCA) Pilot Program: Draft Guidance.