FDA's CBER director says the development of new COVID-19 vaccines can be accelerated by using manufacturing platforms developed for other types of vaccines, thereby reducing the need for product-specific data.
Sponsors interested in developing vaccines for COVID-19 should accelerate the process by using their existing vaccine manufacturing platforms, according to Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research.
The CBER director echoed recent regulatory guidance in emphasizing this point in his remarks at a 14 September joint regulatory...
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.
