Apotex warning letter reflects FDA’s emphasis on company-wide quality systems and invalidated OOS results.
When FDA perceives a corporate pattern of quality failures, it will use warning letters to connect the dots and press for a company-wide response to the failures, as it did in an Aug. 9 warning letter to Apotex Research Private Ltd.
Even though warning letters stem from inspections of individual sites conducted to appraise compliance of those sites’ quality units with...
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.
