FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. If FDA wanted to create that impression, it likely succeeded. They have great impact on most companies that receive them. Dextrum Laboratories Inc. Dextrum Laboratories Inc.

Manufacturing 59

Manufacturing Production Drugs Contract Manufacturing 59

The Pharma Data

JANUARY 27, 2021

Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

The Pharma Data

NOVEMBER 15, 2020

Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.

Clinical Trials 40

Clinical Trials Clinical Trials Production Trials 40

The Pharma Data

MAY 4, 2021

billion, primarily driven by Pfizer CentreOne, Pfizer’s contract manufacturing operation, reflecting sales of legacy Upjohn products to Viatris (4) and remdesivir to Gilead Sciences Inc., Vaccine effectiveness in the study will be inferred through immunobridging to the 16 to 25 year-old population in the pivotal Phase 3 trial.

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharmaceutical Technology

APRIL 12, 2023

The ingredients used in these drugs are high potency, even at small doses, and pose a risk to both human health and cross-contamination with other drugs in a manufacturing environment. This prevents contamination of the elements by the sampled powder.

Manufacturing 130

Manufacturing Production Containment Contamination 130