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Manufacturing

Set Alert for Manufacturing

Woodcock: The US FDA Sets The Stage For Global Quality Dossiers

New approach could eliminate minor differences among authorities, enabling pharmaceutical manufacturing processes to become truly global.

Manufacturing Quality Drug Approval Standards

Generic Industry Not Sold On Benefits Of FDA Emerging Technology Program

FDA’s calls for more generic industry participation in its Emerging Technology Program fell on deaf ears at recent meeting, with several complaining about the costs and value of investing in new manufacturing technologies.

Manufacturing Quality BioPharmaceutical

Latest From Manufacturing

US/India Operation Intercepts Unapproved Drugs, Drug/Device Products

Nearly 500 shipments of illegal and unapproved prescription drugs and combination medical devices were seized at US borders thanks to Operation Broadsword.

Manufacturing Quality

Biogen’s Recipe For Success In Knowledge Management

Biogen’s “recipe-driven qualification” knowledge management program standardizes data collection and reporting in the laboratory, with efficiency gains of 66%.

Manufacturing Quality

US Researchers Working Toward Universal Coronavirus Vaccine

The SARS-CoV-2 outbreak has the federal government working not only on a vaccine candidate specifically targeted at the novel coronavirus but also thinking more broadly about ways to head off future potential pandemics with emerging pathogens.

Vaccines Manufacturing

UK Firms Asked To Check Coronavirus Supply Chain Impact

Amid concerns that the coronavirus outbreak could have an impact on the supply of APIs and other materials sourced from Chinese manufacturers, pharmaceutical companies are to assess their supply chain situation to help ensure patients do not experience medicine shortages.

United Kingdom Manufacturing

Industry Applauds US FDA Plans For Novel Excipients Review Pathway, But Urges Refinement

The FDA’s proposal to establish a separate review path for novel excipients draws industry plaudits and requests for fine-tuning.

Manufacturing Quality

HHS Partners With Pharma On New Disaster Response Biotech Facility

Foundry for American Biotechnology to provide labs and help commercialize technology to protect against and respond to health security threats; first project focuses on validation of devices to make medicines on-site.

Infectious Diseases Manufacturing
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