Agency revises pandemic inspection guidance to explain CRL ‘non-deficiency’ inspection comments and update industry on remote interactive evaluations and post-COVID-19 inspection priorities.
Manufacturing site deficiencies are not behind every recent complete response letter that mentions pandemic site inspection travel delays, the US Food and Drug Administration stresses in a 17 May revision to its August 2020 question-and-answer guidance on inspections during the COVID-19 public health emergency.
The agency is specifically clarifying that it is not issuing CRLs when it lacks information on a manufacturing plant but...
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.
