Quality Systems

Articles

The companies have reached an agreement with the European Commission to update their COVID-19 vaccine supply agreement.

Pfizer and BioNTech Update COVID-19 Vaccine Supply Agreement with EC

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

Podcasts

In this episode of the Drug Solutions Podcast, Chris Spivey, editorial director, interviews Michael Kopcha, Sau Lee, and Cindy Buhse of FDA about not being afraid to try new approaches and how they invite fresh ideas and abundant communication.

Drug Solutions Podcast: FDA Weighs in on Advancing the Science of Pharmaceutical Manufacturing

Richard Denk is Head Sales Containment at SKAN AG, www.skan.ch, Richard.Denk@skan.ch.

Julien Janda is Head of Process and Technology at Takeda.

Markus Stuebchen is Robotics Network Team Lead at Roche.

David Wolton is Global Engineering Technology Lead at Takeda.

Several steps need be taken to achieve lights-out, fully automated operations.

Using Robotics in the Aseptic Manufacturing Facility of the Future

The agency’s Center for Drug Evaluation and Research has launched the new program to increase development of treatment options for patients with rare diseases.

FDA Launches Accelerated Rare Disease Cures Program

The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs, BLAs, or supplements.

FDA Publishes Draft Guidance on Quality Assessments

The drug is the first immunomodulatory COVID-19 treatment approved by FDA.

FDA Approves Olumiant (baricitinib) to Treat COVID-19 in Hospitalized Adults

FDA is limiting the use of Janssen’s COVID-19 vaccine to certain individuals.

FDA Limits Use of Janssen COVID-19 Vaccine

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

Issues related to mifepristone prescribing and dispensing are emerging in the debate over legislation to reauthorize FDA user fees for drugs and medical products.

Escalating Abortion Battle Threatens FDA Authority

Janssen has submitted a marketing authorization application to EMA for the approval of a treatment for patients with HRR gene-mutated metastatic castration-resistant prostate cancer.

Janssen Submits Marketing Authorization Application for Treatment of Metastatic Castration-Resistant Prostate Cancer

Purolite has received the Queen’s Award for Enterprise in the International Trade category.

Regulatory Oversight and Compliance