Data integrity issues bedevil Chinese API firm Suzhou Pharmaceutical Technology and Japanese manufacturer Sato Yakuhin; inadequate sterility controls net warning letters for Brazilian firm Antibioticos Do Brasil, and US firms Horizon, Pharm D, and Aplicare; and lack of a functioning quality unit observed at Canadian firm Intega in FDA GMP warning letters issued in December and January.
A slew of significant data integrity problems were found at Suzhou Pharmaceutical Technology Co. Inc., an active pharmaceutical ingredient manufacturer in Suzhou, China, by FDA investigators in a June 2016 inspection.
FDA said in a Jan. 6 warning letter that the company was falsifying its certificates of analysis (CoAs)...
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.
