Despite in-vitro advances, FDA officials say more work is needed in refining alternative models before agency disbands its weight-of-evidence approach.
Despite promising research on in-vitro approaches to demonstrating bioequivalence of complex orally inhaled and nasal generic drug products, US FDA officials say they still expect generics firms to show bioequivalence with a weight-of-evidence approach that includes comparative clinical endpoint studies.
They made this point at a Jan. 9 public workshop, “New Insights for Product Development and Bioequivalence Assessments of Generic...
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.
