FDA’s fiscal year 2020 budget request calls for spending on figuring out how to regulate new drug manufacturing technologies under the rubric of increasing US domestic manufacturing.
A theme of promoting domestic manufacturing that debuted in the US FDA’s fiscal year 2019 budget request has reappeared in the request for FY 2020, which seeks yet more money and agency staff positions under the rubric of helping to convince global pharmaceutical manufacturers to put down more roots in the US.
Meanwhile, previously initiated efforts to help advance US drug manufacturing excellence would continue under the Trump administration’s proposal. For example,...
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.
