While the measurement of the toxicity of leachables is not always a required parameter, the information collected during these studies could inform future bioprocessing runs.
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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Single-use bags containing toxic or hazardous materials required special handling.
CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.
Continuous processing of 100 g of monoclonal antibody in 24 hours has been demonstrated using lab-scale equipment.
Electronic systems can remove opportunities for individuals to make mistakes or to manipulate the data.
Optimize practices and meet requirements using electronic data integrity systems.
Short tandem repeat profiling is the most validated method to confirm cell line identity and avoid misidentified or cross-contaminated cell lines.
The agency announced a plan to eliminate its existing orphan designation request backlog.
The directorate highlights its 2016 achievements.
The agency announced it is taking steps to increase competition within the prescription drug market.
Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.
The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.
FDA Commissioner Scott Gottlieb announced the agency will hold a public meeting on drug competition as part of its Drug Competition Action Plan.
The company has voluntarily recalled Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level because of a lack of sterility assurance.
The company recalled a variety of products due to the potential of microbial contamination.
The agency’s management board discussed plans for the relocation of EMA at its June 2017 meeting.
The company is voluntarily recalling all unexpired lots of nitroglycerin products produced at its Houston location for potency issues.
Congressional measures lack the support to move forward.
The agency sent a warning letter to A-S Medication Solutions LLC after it found the company didn’t comply with drug listing file requirements.
FDA Commissioner Scott Gottlieb announced the July meeting as part of his commitment to address opioid abuse.
FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.
The three regulatory agencies have agreed to data requirements for development of new antibiotics.
In its June meeting, the agency’s Pharmacovigilance Risk Assessment Committee discussed medicine safety reviews.
FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.
Yusef Manufacturing Laboratories, LLC received an FDA warning letter citing CGMP violations at its Clearfield, UT facility.
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