US FDA is looking at risk-based approach for reporting changes in out-of-stock components such as plastic bioreactor bags, filters and tubing sets that are in short supply.
As pharmaceutical companies encounter disruptions in the supply of single-use systems components required to manufacture monoclonal antibodies and other sterile injectable drugs, the US Food and Drug Administration is preparing advice on quickly switching to alternative sources.
A group within the agency is developing a risk-based approach to making such changes more easily, according to Patricia Hughes,...
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.
