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Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

FDA will use virtual site visits even after resuming active inspections.

FDA to Continue Inspection Efficiencies After Pandemic

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the basics for maintaining an acceptable working relationship between a client and their CDMO.

Productive Client-CDMO Relationships

Mike Hennessy Jr. is the Chairman and CEO of 

AI could provide solutions to critical manufacturing inefficiencies.

Is AI a Panacea for Pharma’s Productivity Gap?

Manufacturers are aligning with pharmacists and providers to blame high drug costs and limited patient access on pharmacy benefit managers.

Pharmacists and Manufacturers Rip PBM Practices

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

FDA continues efforts to incentivize drug manufacturers to follow higher data integrity requirements.

Ensuring CGMP Standards for Data Integrity

FDA once again is taking steps to facilitate the import of less costly prescription drugs.

FDA Moves Forward with State Drug Import Plans

Dupixent (dupilumab), developed by Regeneron Pharmaceuticals in partnership with Sanofi, has received FDA approval for a new indication—treating eosinophilic esophagitis, a chronic inflammatory disease. 

FDA Approves Sanofi’s and Regneron’s Dupixent to Treat Eosinophilic Esophagitis

A new initiative aims to speed the approval of and access to new drugs for young patients around the world, while limiting the number of children needed for testing in clinical trials.

New Guidelines Aim to Advance Pediatric Drug Development

AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.

Vaxzevria Gains Approval in EU as a Third Dose COVID-19 Booster in Adults

EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union. 

Quality Systems