Agency conducts follow-up inspection as Aurobindo's Polepally, India, manufacturing facility looks to move on from crippling OAI designation.
A 2-10 May 2022 inspection by the US Food and Drug Administration of Aurobindo Pharma Limited's Polepally, India, plant challenged the manufacturer to further improve quality at the site, which the FDA had classified as “official action indicated” based on an inspection that ended 27 September 2019.
The OAI inspection result came after a series of no-action-indicated inspections in 2012-2017, according to the FDA’s site inspection classification...
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.
