Look for alternative approaches like sample testing, remote records review and reliance on trusted host nation authorities to fill many inspection gaps – except for OAI re-inspections. Meanwhile, post-emergency planning begins.
Many if not most of the drug adulteration regulatory actions the US Food and Drug Administration takes in fiscal year 2021 will be based on alternatives to FDA inspections that are prevented by coronavirus-related travel restrictions, according to Donald Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
“I anticipate that for the remainder of this fiscal year that a large percentage, and, who knows, perhaps the majority...
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.
