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Federal Register Notice: FDA releases a draft guidance, on Humanitarian Use Device designations.

CDRH Draft Guidance Urges More Women in Trials

[ Price : $8.95]

A new CDRH draft guidance aims to increase women participation in medical device clinical trials and to ensure that data from such...

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.

FDA, Austen BioInnovation Sign MOU on Biomaterials

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FDA and Austen BioInnovation Institute sign a Memorandum of Understanding to collaborate on the safe and effective use of biomater...

FDA Needs More Authority on Drug Shortages: GAO

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GAO reports that FDA needs more authority to effectively handle drug shortages, and HHS responds for the agency that it supports t...