Agency will expand staffing to address requests for help from its Emerging Technology Program, while “graduating” technologies with which it gains sufficient experience.
To further accelerate adoption of new pharmaceutical manufacturing technologies, the US Food and Drug Administration’s Center for Drug Evaluation and Research is adding staff to its Emerging Technology Program and “graduating” technologies to standard quality assessment pathways.
Larry Lee, who chairs the program, told the FDA’s Pharmaceutical Quality Symposium on 27 October that the changes are part...
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.
