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Panel to Discuss sNDA for HIV-associated Neuropathy

[ Price : $8.95]

Federal Register Notice: FDAs Anesthetic and Analgesic Drug Products Advisory Committee will meet 2/9.

Panel to Discuss Pediatric Safety Reviews

[ Price : $8.95]

Federal Register Notice: FDAs Pediatric Advisory Committee will meet 1/30-31/12 to discuss several pediatric-focused safety review...

FDA OKs Intervet NADA for Canine Incontinence

[ Price : $8.95]

Federal Register Final rule: FDA approves an Intervet NADA for use of estriol tablets to control canine urinary incontinence.

Guidance on Humanitarian Use Devices

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance, on Humanitarian Use Device designations.

Rep Cited for False, Misleading Latuda Statements

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion says that a Sunovion sales representative made false or misleading statements about La...

OPDP Says Qutenza Booth Didnt Give Risk Info

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion says that a convention display booth for NeurogesX Qutenza failed to communicate risk ...

Gilead Submits Truvada sNDA for New Indication

[ Price : $8.95]

Gilead says it is seeking a new indication for Truvada for pre-exposure prophylaxis to prevent HIV-1 infection.

Enforcement Discretion Under DESI Still Being Clarified

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Attorney Kurt Karst says FDA is further clarifying its enforcement discretion policy for drugs being marketed pending a DESI deter...

CVM Releases Info to Help Choramine-T Sponsors in Fish Disease

[ Price : $8.95]

FDA publishes safety and effectiveness information to support a new animal drug application (NADA) for use of chloramine-T for con...

FDA Restores Higher Simvastatin Dose with Amiodarone

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FDA says it erred in reducing the dose limitation for simvastatin when used in conjunction with amiodarone.