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

Articles

The Consolidated Appropriations Act for 2023 provides FDA with a $6.6 billion total budget.

Massive Government Spending Bill Tackles Key FDA and Research Issues

The complaint states the company introduced adulterated drugs into interstate commerce that were manufactured, processed, packed, or held under conditions that defy current good manufacturing practice (CGMP) requirements. 

Consent Decree Against Oklahoma Drug Compounder Enters Federal Court

FDA has announced that bebtelovimab is not currently authorized for emergency use in any region of the US. 

FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region

Amanda Guiraldelli is Scientific Affairs Manager, United States Pharmacopeia, Rockville, MD.

This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017. 

Evolution of Analytical Procedure Validation Concepts: Part II– Incorporation of Science and Risk-based Principles in ICH Q14 and Q2(R2) Guidelines

Adam C. Fisher, Phd, is Director of Science Staff, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA.

Some manufacturers are developing smaller, more mobile drug manufacturing processes for point-of-use patient care. 

Nurturing Manufacturing Agility

FDA struggles to track shortages caused by a rise in demand.

Rising Demand Drives Drug Shortages

Peter Zipfell is product marketing specialist, CMD Software, Thermo Fisher Scientific.

The most safe and effective therapies demand the highest data quality. 

Driving Data Quality and Ensuring Compliance Using Modern CDS Solutions 

Ferring Pharmaceuticals’ Rebyota was approved for the prevention of recurrence of Clostridioides difficile infection.

FDA Approves First Fecal Microbiota Product

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

Overall industry growth conceals growing numbers of smaller, faster-paced, adaptable corporate structures.

Shining a Light on Junior Pharmaceuticals

Somnath Mishra, Somnath.mishra@shabas.net, is president at Shabas Solutions LLC.

William Hauck is senior associate at Shabas Solutions LLC.

Zachary Royal, is senior consultant at Shabas Solutions LLC.

Robert Michalik is advisor (Quality and Corporate Compliance) at Shabas Solutions LLC.

QMM is an evolutionary advancement in FDA’s quality management maturity initiative that provides industry with a viable methodology to assess and improve manufacturing quality and supply chain reliability. 

Quality Systems