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FDA Rejects Hearing Aid Standardization

[ Price : $8.95]

FDA denies a petition asking it to standardize hearing aid features in new over-the-counter hearing aids and rate them.

FDA Partnership on Rare Neurodegenerative Diseases

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FDA joins the National Institutes of Health in launching a Critical Path for Rare Neurodegenerative Diseases public-private partne...

FDA Determines Review Period for Migraine Drug

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Eli Lillys migraine drug Re...

Bob Temple Gets New Title, Role Remains the Same

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CDER director Patrizia Cavazzoni removes Bob Temples deputy Center director title and renames him senior advisor for clinical scie...

MAPP on SGEs Representing Sponsors Before FDA

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CDER issues a Manual of Policies and Procedures for instances in which a CDER special government employee wants to represent a spo...

CDER Planning Guidance on Clinical Trial Modernization

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CDER Office of Compliance director Don Ashley tells a regulatory conference that the Center is planning a guidance document on the...

Texas Longhorn RX Producing Illegal Drugs: FDA

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FDA warns Texas Longhorn RXs Talon Pharmacy of Boerne, Boerne Texas, about selling adulterated compounded drug products.

$2 Million FDA Grant to Marker Therapeutics

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FDA grants $2 million to Marker Therapeutics to support the treatment arm in a Phase 2 trial of its T-cell candidate to treat pati...

Preserve Access to Compounded Hormones: APC

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The Alliance for Pharmacy Compounding calls on FDA to reject recommendations in a National Academies report and instead maintain p...

Draft Guide on Device Maker Computer Software Assurance

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Federal Register notice: FDA makes available a draft guidance entitled Computer Software Assurance for Production and Quality Syst...