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July 23, 2019

Vol. 16 No. 140

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Novartis’ Sickle Cell Med Nabs FDA Priority Review

The company’s submission is supported by Phase 2 trial results showing the treatment reduced the median yearly rate of VOCs that led to healthcare visits by 45.3 percent compared to a placebo. Read More

Spanish Regulator Cites Drugmaker for Quality Fraud

The firm had stopped recording deviations and out-of-specification results for various drug products since January. Read More

FDA Hits Florida OTC Drugmaker for Quality Violations

The facility’s procedures for handling product complaints lacked time frames for complaint investigations. Read More

Drug Distributor Warned for Drug Listing Errors

The agency noted that the product’s labeling lists its active ingredient as diphenhydramine hydrochloride, but the NDC listing says the active ingredient is bromodiphenhydramine hydrochloride. Read More

CDER Issues Guidance on Next Generation Sequencing Data for Antiviral Products

The guidance says FDA’s Division of Antiviral Products will accept data from most NGS platforms, but sponsors ‘should submit a detailed protocol that describes sample processing and NGS analysis procedures.’ Read More