Manufacturers warned to keep better electronic records and not falsify data in recent warning letters, ICH adds three residual solvent limits for pharmaceuticals, and the Polish authority hits firm for GMP noncompliance.
The US Food and Drug Administration’s recent warning letters to drug manufacturers and active pharmaceutical ingredient manufacturers in the US and India show that data integrity problems are not going away anytime soon, despite the inspection hiatus that was brought on by the coronavirus pandemic.
Also, the International Council on Harmonization proposes to add three new residual solvents to the list of solvents considered safe...
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.
