As the main cause of drug shortages is poor manufacturing quality, the best way to prevent them is to get ahead of the curve on quality, says a Pew/ISPE industry survey report.
Pharmaceutical manufacturers should work to prevent drug shortages by averting quality failures that could trigger them, a Jan. 12 report from the Pew Charitable Trusts and the International Society for Pharmaceutical Engineering concludes.
The report recommends the use of periodic risk assessments, which identify potential compliance risks across a company’s supply chain, and...
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.
