Joe Biden’s presidential campaign now has a plan to address supply chains and encourage US-based manufacturing of prescription drugs. That affirms the unlikely national prominence of the issue – and reduces the chances of meaningful legislation this year.
Here is a topic that most would not have predicted as an early theme for the US Presidential campaigns: a call for the US government to create a list of “critical drugs” to target for special incentives and supply protections.
The idea of a “critical drugs” list isn’t new. It has been proposed in legislation and in comments to the...
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.
