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Novartis Plans Cardiac Drug Application by End of Year

[ Price : $8.95]

Novartis says it plans to complete its FDA filing for a new drug to treat heart failure with reduced ejection fraction by the end ...

Respironics Class 1 Recall of Ventilators

[ Price : $8.95]

Respironics begins a Class 1 recall of its Esprit V1000 and V200 Ventilators that were installed with third-generation power suppl...

FDA Clears BrainScopes Ahead 100 Brain Injury Evaluator

[ Price : $8.95]

FDA approves a BrainScope Co. de novo classification petition allowing the marketing of its Ahead 100 device that uses a patients ...

Public Docket on First Generic ANDA Submissions

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Federal Register Notice: FDA opens a public docket on its proposed criteria for first generic ANDA submissions.

Comments Sought on Tobacco Product Studies

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Federal Register Notice: FDA seeks comments on consumer studies on perceptions of modified risk tobacco products.

CDER Releases SDTM Validation Rules

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Federal Register Notice: CDER is making available: Validation Rules for Study Data Tabulation Model (SDTM) Formatted Studies.

Guidance on Vaginal Microbicides for HIV

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Federal Register Notice: FDA is releasing a guidance: Vaginal Microbicides: Development for the Prevention of HIV Infection.

Gilead Buys Priority Review Voucher for $125 Million

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Knight Therapeutics sells to Gilead Sciences for $125 million its Neglected Tropical Disease Priority Review Voucher that was gran...

FDA Grants Merrimack Pharma Fast Track Status for MM-398

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FDA grants Merrimack Pharmaceuticals a fast track designation for MM-398 (nanoliposomal irinotecan injection) for treating patient...

Chemistry Question-based Review MAPP

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CDERs Office of Pharmaceutical Science issues a MAPP on using a question-based review template.