Quality/GMPs

This article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.

The US Congress approved a federal spending package that increases funding for a range of programs to advance health and medicine.

Biotech companies and medical product manufacturers have condemned the invasion of Ukraine, while also looking to maintain supplies of essential medicines.

FDA’s CDER continues to make rare diseases a priority with drug approvals and programming to speed therapeutic development.

EMA’s PRIME scheme has enabled life-changing medicines to become available to patients at a faster rate.

Pfizer has received Breakthrough Therapy Designation from FDA for its RSV vaccine candidate for prevention of RSV illness in infants by active immunization of pregnant women.

The authors review some of the monoclonal antibody candidates that reached Phase III clinical trials but were discontinued at later stages.

FDA has revised the Emergency Use Authorization for sotrovimab.

Califf will face challenges that include COVID-19, opioids, and user fees.

Auditors must have access to the batch records of the activities they are reviewing, says Siegfried Schmitt, vice president, Technical at Parexel.

EMA has recommended approval of Spikevax for children aged 6 to 11.

Pfizer and BioNTech receive positive opinion for COVID-19 vaccine booster in adolescents 12 through 17 years of age in the EU.

FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure.

FDA licenses Certara’s Immunogenicity Simulator to research and evaluate immunogenicity in protein-based therapeutics.

Medicago and GSK have announced that Health Canada has approved COVIFENZ, an adjuvanted plant-based COVID-19 vaccine.

USP is developing mRNA quality guidelines to help companies and regulators bring innovative medicines to market faster.

The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information on medicines in the European Union.

FDA officials and their scientific advisors have come down hard on clinical development programs that rely on study results from a single foreign country, instead of from multi-regional trials following harmonized R&D standards.

The EC approved AstraZeneca’s Saphenlo (anifrolumab) for the treatment of active autoantibody-positive systemic lupus erythematosus.

The integration of modern software tools can make the acquisition and analysis of MS data more efficient, accurate, and compliant.

The agency recommended 53 new active substances in 2021, up 35% from 2020.

The agency’s safety committee is assessing reported cases of period irregularities associated with Comirnaty and Spikevax mRNA vaccines.

Guidance published during the pandemic has been updated to include content requirements for summary safety reports.

Thermo Fisher Scientific's solution for cell and gene therapies involves a combination of cold chain logistics, serialization compliance, and distribution

Novavax’s COVID-19 vaccine has received conditional marketing authorization from MHRA and provisional approval from Medsafe.