FDA warning letter to South Korean manufacturer Celltrion cites an extensive list of problems related to inadequate contamination controls and shows how companies launching biosimilars can be tripped up by GMP compliance problems.
An FDA warning letter issued on Jan. 26 to Celltrion Inc. in Incheon, South Korea cited an extensive number of GMP violations with a good number of these problems stemming from lax contamination controls.
Since the summer, there has been a spate of drug GMP warning letters going to foreign drug manufacturers and particularly...
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.
