Containment Contamination Contract Manufacturing Trials 
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. Two device manufacturers received Warning Letters for QSR violations (QSR is FDA’s label for cGMP requirements applicable to medical device manufacturers).
The Pharma Data
JANUARY 27, 2021
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.
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The Pharma Data
NOVEMBER 15, 2020
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.
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.
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. Currently mostly outsourced, there are signs that CMOs are beginning to make investments in containment capabilities, to capture emerging opportunities.
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