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Current Issue
Wearable Injection Devices Address Delivery Challenges
Advances in wearable devices have made it possible to deliver high-volume, high-viscosity biologics.
When One Therapy No Longer Fits All
More diversified therapies and tighter payer budgets will challenge bio/pharma companies to think outside the industry.
Outsourcing Analytical Processes in Biologics Development
Outsourcing analytics can be a cost-effective way for biopharma companies to adapt to new technologies and regulations.
Webcasts
Outsourcing
Catalent Adds Clinical Supplies Capacity
A $5.5-million expansion at its Philadelphia, PA clinical supplies facility gives Catalent additional packaging and storage capacity.
Cost Cutting to Drive 12% Growth in CRO Outsourcing Through 2021, New Study Finds
A new study by the Business Research Company reveals prominent contract research organization outsourcing trends.
New Jersey Firm Gets FDA Warning Letter
FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.
Outsourcing Analytical Processes in Biologics Development
Outsourcing analytics can be a cost-effective way for biopharma companies to adapt to new technologies and regulations.
Standards/Regulations
CDER Publishes Drug Safety Report
FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.
FDA Seeks to Advance Treatments for Opioid Use Disorder
The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.
FDA Publishes Q&A on GMPs for APIs
The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.
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