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News From Around The Industry

CWWeekly Features

EU General Data Protection Regulation (GDPR) Enforcement Set to Begin on May 25

The European Union (EU) General Data Protection Regulation (GDPR) is set to become enforceable in just over a month, which is causing new work for those in clinical research, and carrying with it a brutal fine for noncompliance.

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FDA Releases Guidance on Next-Generation Sequencing with an Eye on Easing Path to Market

The FDA published a new draft guidance outlining how early Sponsors should incorporate pediatric patients, and relevant age groups, for systemic therapies for atopic dermatitis (AD). The agency previously recommended that Sponsors submit pre-approval data on the use of topical products, but did not recommend pediatric studies of systemic drugs until after adult approval.

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FDA Releases Final Guidance for Special Protocol Assessments

The FDA finalized guidance on its special protocol assessment (SPA) program that offers sponsors an advanced declaration from the agency that their trial designs, clinical endpoints and statistical analyses are acceptable.

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Trial Results & Briefs

FDA Recommends Early, Pre-Approval Trials in Pediatrics for Systemic Dermatitis Drugs

The FDA published a new draft guidance outlining how early Sponsors should incorporate pediatric patients, and relevant age groups, for systemic therapies for atopic dermatitis (AD). The agency previously recommended that Sponsors submit pre-approval data on the use of topical products, but did not recommend pediatric studies of systemic drugs until after adult approval.

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KEYTRUDA Monotherapy Met Primary Endpoint in Phase III Study

Merck announced that the pivotal Phase III KEYNOTE-042 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer met its primary endpoint of overall survival.

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