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.
Quality/GMPs
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Digitalization of QbD Risk Assessments
The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
Subjectivity in Quality Risk Management
The authors discuss subjectivity in the ICH Q9 (R1) guidance document.
Phase-appropriate Compliance for Cell and Gene Therapies
Understanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.
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FDA will use virtual site visits even after resuming active inspections.
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the basics for maintaining an acceptable working relationship between a client and their CDMO.
AI could provide solutions to critical manufacturing inefficiencies.
FDA once again is taking steps to facilitate the import of less costly prescription drugs.
Dupixent (dupilumab), developed by Regeneron Pharmaceuticals in partnership with Sanofi, has received FDA approval for a new indication—treating eosinophilic esophagitis, a chronic inflammatory disease.
AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.
EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union.
A new initiative aims to speed the approval of and access to new drugs for young patients around the world, while limiting the number of children needed for testing in clinical trials.
PTC Therapeutics has received a positive opinion from EMA for Upstaza for the treatment of AADC deficiency.
The final guidance addresses safety aspects of container and carton labeling design.
The agency is asking drug manufacturers to ensure a strong supply chain by developing risk management plans.
FDA has approved Mounjaro (tirzepatide) injections as a treatment to improve blood sugar control in adults with type 2 diabetes.
Pfizer and BioNTech’s COVID-19 vaccine has been granted EUA for booster doses in children five through 11 years of age.
The companies have reached an agreement with the European Commission to update their COVID-19 vaccine supply agreement.
To build trust and ensure a high-quality product, companies must be sure their contracts are firm and their lines of communication even firmer.
CDMOs offer expertise and customization options for sponsors of orphan drugs.
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.
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 is limiting the use of Janssen’s COVID-19 vaccine to certain individuals.
Issues related to mifepristone prescribing and dispensing are emerging in the debate over legislation to reauthorize FDA user fees for drugs and medical products.
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.
Purolite has received the Queen’s Award for Enterprise in the International Trade category.
Kapruvia has been approved by the European Commission for the treatment of moderate-to-severe pruritis in hemodialysis patients.
The new company has been appointed as a channel partner for Ireland by TSI Inc., a particle counter manufacturer.
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