Agency provides new details on plans for various remote methods of assessing manufacturing establishments that became popular when investigators were prevented by COVID-19 pandemic travel restrictions from visiting sites in person.
The US Food and Drug Administration on 22 July said it will keep doing remote regulatory assessments of drug manufacturing plants, clinical investigator sites and other FDA-regulated establishments, even when the COVID-19 pandemic no longer prevents travel for site inspections – and provided some insight into why.
The experience the agency developed with various types of remote assessments during the public health emergency “has identified significant benefits...
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.
