OTCs and other "no-application" products remain a drag on overall quality, agency finds in annual quality report, while India and China continue to pose challenges.
The US Food and Drug Administration's scrutiny of consumer drug quality and Asian manufacturing facilities is likely to intensify, given the chief findings of the agency's second annual “state of pharmaceutical quality” report.
Many of the new report’s findings mirror those of the agency’s first report, issued in May 2019. (Also see "
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.
