A more effective approach to quality assurance could result from an operational pause at a Pfizer plant in India, where the company is responding to US FDA inspectional observations of poor data integrity and inadequate investigations that are expected to result in a warning letter.
The quality culture journey Pfizer Inc. embarked on when it acquired Hospira’s sterile injectables operation in 2015 hit another inflection point recently when Pfizer suspended production at a plant in India to remediate quality issues US FDA identified during an inspection.
FDA already has publicized the April 3 inspection’s “official action indicated” result, which means it is only a matter of...
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.
