Contracts in works also would help track APIs, promote gene therapy standards, improve drug compounding, help extend shelf lives for US stockpile products and improve budget execution.
The US Food and Drug Administration has been lining up contractors to help it with a variety of drug quality-related initiatives, most notably an ambitious effort to assess the quality management maturity of individual pharmaceutical manufacturing facilities.
The agency already has enlisted the help of St. Gallen University and Dun & Bradstreet for a survey-based study, while...
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.
