Compliance Contamination Contract Manufacturing Drugs 
Roots Analysis
APRIL 15, 2024
These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.
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. The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022.
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Roots Analysis
JANUARY 12, 2023
Considering the vast potential of cell therapies in the treatment of rare disorders and sufficient body of evidence validating the clinical benefits / therapeutic potential of this complex class of biologic drugs, cell therapies have garnered considerable attention of players engaged in the healthcare industry, in the past few years.
The Pharma Data
NOVEMBER 15, 2020
a publicly traded biopharmaceutical company, from 2012 to December 2019, managing its international, legal, quality, intellectual property and compliance functions, after serving in other executive roles at Acorda starting in 2004. drug development initiative from 2012 to February 2019. Before joining Acorda, Ms.
Pharmaceutical Technology
JUNE 14, 2023
The number of high-potency drug approvals has increased over the last decade, driven by the increasing use of APIs (Active Pharmaceutical Ingredients) in the pipeline and among marketed drugs. Premium specialized equipment is necessary because high containment facilities call for the separation of the operator from the product.
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