The number of sterile drug recalls from glass delamination, breakage and other sources of contamination has dropped dramatically since 2010, with the exception of several spikes in 2013 and 2014. FDA and other officials attribute the drop to better risk assessments and fuller evaluations of product formulations' interactions with container closure systems. The industry is also exploring the use of a new, reportedly sturdier type of glass vial that eliminates delamination.
The pharmaceutical industry drew praise from FDA for improving glass handling practices and conducting more robust container closure studies, which appears to have reduced the number of sterile drug recalls due to glass delamination, breakage and other glass-related factors.
Pharmaceutical industry officials, representatives of the glass industry and FDA officials discussed some of the progress being made in reducing...
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
