Regulatory/GMP Compliance

Novartis Gets EMA Approval for Two European Commercial CAR-T Manufacturing Sites

August 07, 2020

The European Medicines Agency recently approved two European Novartis sites in France and Switzerland for the commercial manufacturing of chimeric antigen receptor T-cell cell therapies.

Debate Accelerates Over Who Gets COVID Vaccine First

August 03, 2020

As biopharma companies and research institutes advance the development of COVID-19 vaccines, policy makers and health officials are debating strategies for ensuring fair and equitable distribution of anticipated preventives.

Aseptic Processing Practices: Reviewing Three Decades of Change

August 01, 2020

Technologies in use and on the horizon could change aseptic processing in ways that seemed inconceivable years ago but approaches to aseptic process validation still need to move beyond their 1970s roots.

Regulating Raw Materials Testing

August 01, 2020

Efforts are already underway to harmonize standards and regulatory approaches for testing of raw and ancillary materials, but continuous improvement is required.

Global Regulatory Collaborations Aim to Speed Access to New Vaccines and Drugs

August 01, 2020

Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally.

Training During a Pandemic

August 01, 2020

When in-person training may not be feasible, there are still opportunities to ensure employees receive the required training, says Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.

EMA Starts Review of Dexamethasone as COVID-19 Treatment

July 30, 2020

EMA has started a review of dexamethasone as a treatment for adults with COVID-19 who require respiratory support and have been admitted to hospital.

EC Grants Marketing Authorization for Remsima

July 29, 2020

Celltrion Healthcare has announced that the EC has granted marketing authorization for its subcutaneous formulation of Remsima (infliximab, CT-P13).

Stakeholders Seek Increased User Fee Support for Biologics

July 24, 2020

Patient advocates, research experts, and industry are calling for more user fee revenues to support CBER programs to advance innovative therapies.

EMA Sets Up Infrastructure to Support Real-World Monitoring of COVID-19 Vaccines

July 23, 2020

The European Medicines Agency has set up an infrastructure to support real-world monitoring of the efficacy and safety of COVID-19 vaccines and treatments.