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Eisai Scraps Investigational GERD Drug

[ Price : $8.95]

An FDA complete response letter causes Eisai to abandon its global development program of rabeprazole sodium extended-release caps...

Li-Cor Drug Master File for Imaging Agent

[ Price : $8.95]

Li-Cor Biosciences says it has registered IRDye 800CW N-succidimidyl ester under an FDA drug master file.

Nominations Sought for Tobacco Panel

[ Price : $8.95]

Federal Register Notice: FDA requests nominations for members to serve on its Tobacco Products Scientific Advisory Committee.

CVM Warns on Transdermal Cat Device Risk

[ Price : $8.95]

CVM issues a warning on the risk of bone fractures with a Bioject transdermal vaccination system device for cats receiving Purevax...

DDMAC Cites Pfizer Web Page on 3 Product 'Misbrandings'

[ Price : $8.95]

DDMAC says Pfizer misbranded several drug products when it discussed their efficacy on a its Web site without providing any risk i...

Advocates Push Breast Implant Ban

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Consumer advocates tell FDA advisors that the inability of breast implant manufacturers to track patients in post-approval studies...

Comments Extended on Protecting Human Research Subject Regs

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Federal Register Advanced notice of proposed rulemaking: The comment period is extended until 10/26 on how to modernize current re...

Dedicated Drug Development Liaison Staff Planned

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FDA releases a draft performance agreement for the PDUFA 5 reauthorization.

Guidance on NDA/ANDAs Format for PET Drugs

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Federal Register Notice: FDA releases a guidance on the format for NDA and ANDAs for positron emission tomography drugs.

PhRMA Defends Patent Settlements in Wake of FTC Report

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PhRMA defends industry patent settlements in the wake of an 8/31 FTC report on authorized generics.