Quality/GMPs

In an FDAVoice blog post, the CDER director highlighted two recent scientific advances.

The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.

FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.

This column presents a data case study of a laboratory refrigerator and its qualification performance over five days, with important lessons for using average and individual results, as well as user requirements.

The opening presentation gives the company a chance to put their best foot forward, according to Siegfried Schmitt, principal at PAREXEL.

This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.

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.

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.