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Info on Clinical Investigations Oversight Sent to OMB

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Federal Register Notice: FDA submits a collection of information on a draft guidance on a risk-based approach to the oversight of ...

Guidance on ANDA Stability Testing

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Federal Register Notice: FDA releases a draft guidance on stability testing of drug substances and products for ANDAs.

Guidance on Pre-Storage Leukocyte Reduction of Blood/Components

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Federal Register Notice: FDA releases a guidance on pre-storage leukocyte reduction of whole blood and blood components intended f...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Aino Co., Ltd. of North China Pharmaceutical Group, Arriol International, Atlant...

Ranbaxy Misses 9/21 Generic Diovan Launch

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The Economic Times reports that Ranbaxy missed its intended 9/21 launch of a generic form of Novartis Diovan.

CDER Official Reviews Outsourcing Responsibilities

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CDER Office of Manufacturing and Product Quality director Steven Lynn reviews drug sponsor responsibilities when using outsourced ...

CDER Rolling Out New Field Alert Report System

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A CDER official unveils the agencys plans for a new automated field alert report system for drug manufacturers to use when reporti...

A Year Later, Custom Medical Surgical Kit Recall is Class 1

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A year after the event, FDA now says a Custom Medical Specialties recall of 14 types of surgical kits was Class 1.

FDA Awards $5 Million Contract for Bioequivalence Studies

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FDA awards Vince & Associates a five-year contract for research on bioequivalence of branded and generic drugs.

Reckitt Benckiser Pulling Suboxone Tablets

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Reckitt Benckiser withdraws its Suboxone tablets and asks FDA to order companies making products containing buprenorphine to take ...