Hogan Lovells Publications

FDA proposes streamlining combination product regulations

On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule...

Hogan Lovells Publications

FDA finalizes guidances for NGS-based tests

On April 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidances on the oversight of next generation sequencing (NGS)-based in vitro diagnostic tests....

Hogan Lovells Publications

Is it a drug, device, biologic, or combination product? FDA issues final guidance on classification

On September 26, 2017, the Food and Drug Administration (FDA) published a final guidance document providing further clarity on how FDA classifies a product as a drug, device,...

Hogan Lovells Publications

FDA Cleared First DTC Genetic Tests for Health Risks

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the...

Hogan Lovells Publications

A "Cure" for Combination Products: 21st Century Cures Act Mandates Greater Transparency of Combination Product Designations

The 21st Century Cures Act ushers in significant changes to the regulatory review of drug/biologic/device combination products. The regulation of combination products has been somewhat...

Hogan Lovells Publications

The more the merrier: Knowing when, why, and what to tell FDA about combination product postmarket events

The FDA announced yesterday that it is issuing final regulations governing postmarketing safety reporting for combination products. The regulations become effective January 19, 2017, but...

Published Works

Antimicrobial resistance concerns leach into FDA's classification of wound dressings containing drugs

On September 20–21, 2016, FDA convened an advisory panel to seek recommendations about the regulatory classification for wound dressings containing drugs. These devices are widely...

Hogan Lovells Publications

New FDA Reporting Tool Encourages Whistleblowers

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