Two Indian firms – Biocon and Dr Reddy’s – have received crucial establishment inspection reports (EIRs) from the US FDA amid improved compliance levels at their manufacturing sites.
Two Indian firms seeking to set right compliance deviations at their sites appear to have made notable gains. Biocon Ltd. and Dr. Reddy's Laboratories Ltd. have received establishment inspection reports [EIRs] from the US Food and Drug Administration at their sites in Bangalore and Duvvada respectively in India.
The EIR for the Biocon’s aseptic drug product facility states that the inspection stands closed, though the FDA has classified...
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.
