With inspectorate grounded by COVID-19, agency cannot clear remediated facilities or approve related applications – unless industry has a better idea.
Drug manufacturers that have remediated serious quality problems identified during US Food and Drug Administration inspections will have to keep waiting until after the coronavirus pandemic subsides for the follow-up site inspections that could green-light resumption of site-related application reviews – at least for the time being.
With the FDA’s inspectorate grounded since mid-March for all but the agency’s most pressing “mission-critical” inspections, the pharmaceutical industry has...
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.
