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Bayer HealthCare Pharmaceuticals AG

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www.bayerpharma.com

Latest From Bayer HealthCare Pharmaceuticals AG

Keeping Track: Turalio, Nubeqa And Accrufer Mark Trio Of Novel Drug Approvals

The latest drug development news and highlights from our US FDA Performance Tracker.

Approvals Drug Review

ParaGard TV Spot Misrepresents Contraceptive’s Risks, US FDA Says

‘Untitled’ letter is FDA's third in the past eighteen months to target promotions for women’s health products. In the case of advertisement for CooperSurgical's copper-containing intrauterine device, which is regulated as a drug, the agency took issue with distracting visuals and reliance on superimposed text.

Advertising, Marketing & Sales Ad Complaints

Pregnancy Labeling Needs Clearer, More Consistent Language, US FDA Panel Says

Language used to describe drug effects on pregnancy and lactation is ambiguous, complex and not useful to prescribers, advisors say, also urging FDA to use graphics or rating scales to convey the strength of the animal and human data on use during pregnancy.

Advisory Committees Drug Safety

Aradigm's Linhaliq Suffers 'No' For Reducing Time To Exacerbations At US FDA Panel

Discordant results on Phase III primary endpoint in non-cystic fibrosis bronchiectasis patients troubled advisory committee members, although some suggested they would be more open to approval based upon secondary endpoint data on reduction in exacerbation frequency.

Advisory Committees Drug Review
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