US FDA official warns the pharmaceutical industry that investigators will continue to look for data integrity problems during inspections, and discusses “red flags” observed in inspections.
US FDA investigators will continue to focus on data integrity problems in preapproval and GMP surveillance inspections, said an FDA official who also revealed some “red flags” observed during inspections that could trigger a Form 483 observation or even a warning letter.
Sharon Thoma, a field investigator in FDA’s Minneapolis District Office, also shared some insights on ensuring a smooth inspection at...
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.
