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Solicitor General Asked for Comment on Classen Case

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Attorney Christine Norris says the Supreme Court may hear appeals from a lower court decision in Momenta v. Amphastar after hearin...

Comments Sought on Influenza Reagent Guidance

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Federal Register Notice: FDA seeks comments on a guidance on reagents for detecting specific novel influenza A viruses.

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Federal Register Notice: FDA submits a collection of information on a draft guidance on a risk-based approach to the oversight of ...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Federal Register Notice: FDA releases a draft guidance on stability testing of drug substances and products for ANDAs.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...

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 ...

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...