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FDA Advisory Panel to Review Diabetes Drug

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Federal Register notice: FDA announces a 10/18 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss a Novo Nor...

Joint Panel to Mull Opioid Dependence NDA

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Federal Register notice: FDA joint advisory committee meeting reviews Indivior Pharmaceuticals NDA for buprenorphine subcutaneous ...

Comments Sought on REMS Standards Initiative

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Federal Register notice: FDA seeks public input on the design of its REMS Platform Standards Initiative, as well as methods and be...

7 Recalled, Failed Devices Cost Medicare $1.5 Billion: IG Report

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The HHS Inspector General says that seven recalled or prematurely failed cardiac devices cost Medicare $1.5 billion over nine year...

Draft Guide on Diagnostic Ultrasound Systems and Transducers

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FDA makes available a draft guidance on Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.

Two FDA Guidances on Advancing Complex Drug Generics

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FDA releases two guidances as part of its initiative to make it easier to introduce generic copies of complex drugs.

FDA Guide on Requesting Rationales of Significant Decisions

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FDA posts a guidance on Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A.

Guidance on Diagnostic Radiology Display 510(k) Submissions

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FDA releases a guidance on Display Devices for Diagnostic Radiology that is intended to assist industry in preparing premarket not...

Gottlieb Visits FDA Staff in Puerto Rico

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FDA commissioner Scott Gottlieb flies to Puerto Rico 9/29 to see firsthand the devastation caused by Hurricane Maria.

CDER Recognizes CDISC Clinical Data Standards Guide

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Federal Register notice: CDER announces support for version 1.1 of Clinical Data Interchange Standards Consortium, Analysis Data M...