Quality/GMPs

The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.

By understanding potential material change, the impact on patient safety can be understood and mitigated.

Improved real-time visibility during all segments of handling, transportation, and delivery is keeping costs low and reliability high while helping time- and temperature-sensitive biopharmaceuticals to go the distance without incident.

Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.

Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.

The European Commission has approved Cosentyx for the treatment of various childhood arthritic conditions.

The European Commission has approved Xenpozyme as the first treatment for ASMD.

The action plan will span over five years and will fulfill a requirement of the Accelerating Access to Critical Therapies for ALS Act.

Regulators wish to expand and clarify methods for obtaining information on medicines used by or needed for pregnant and lactating individuals through clinical trials and postapproval studies.

The new guidance outlines the approach the MHRA intends to take for products approved or pending in a decentralized procedure or mutual recognition procedures.

FDA is at a pivotal moment because of important gains in medical treatment based on science.

The agency will review laboratory study and CMC data on the bivalent vaccine that targets two strains of the SARS-CoV-2 virus.

Lessons learned from the COVID-19 pandemic about the benefits of international collaboration were discussed in a May 2022 workshop.

Measure tackles infant formula, cosmetics, diagnostics plus drug development and access.

MHRA has been accepted as a full member of three international work-sharing partnerships aimed at making sure medicines and medical devices are regulated safely and efficiently across the world.

The new draft guidance describes a standards recognition program for regenerative medicine therapies.

The draft ICH Q9(R1) document details the importance of quality risk management principles.

In the report, the agency presents the activities it accomplished in 2021 to protect and promote public health.

The European Commission has granted conditional marketing authorization to the Janssen Pharmaceutical Companies of Johnson & Johnson for CARVYKTI (ciltacabtagene autoleucel), a cell therapy for treating multiple myeloma.

The agency’s Medicines Shortages Steering Group has adopted a list of critical COVID-19 vaccines and treatments so they may be monitored for potential shortages.

Roche has received approval from the European Commission for Lunsumio (mosunetuzumab), the first CD20xCD3 T-cell engaging bispecific antibody for treating follicular lymphoma.

FDA has approved GSK’s vaccine for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.

One get obtain a clearer assessment of gene-editing outcomes through more exacting analytical tools.

Having a clear clinical strategy early on can shave time off overall development projects.

Extensive work has greatly expanded the possibilities for fetal bovine serum sourcing.

Thanks to technological advances, process chromatography challenges are surmountable, but increasingly complex therapies in the pipeline will demand more efficient processes in the future.

The complex nature of biologics creates challenges for GMPs in sterile manufacturing, and the EU’s Annex 1 is making an impact.

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

When considering whether to outsource work to a CRO, there are a number of factors to assess, including the type of work that may be outsourced, regulatory considerations, and needs for the study.

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