In US FDA’s draft, mandated by in the current user fee legislation, contract manufacturers can also vie for a designation. CDER ETT and CBER CATT teams will play a key role in the process.
The US Food and Drug Administration’s draft guidance on the Advanced Manufacturing Technology Designation Program envisions a central role for existing drug and biologic center technology teams in assessing whether a novel manufacturing method qualifies for the new designation.
FDA “strongly recommends” those interested in participating in the AMT program first engage with CDER’s Emerging Technology Team (ETT)...
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.
