After realizing some generics don’t work, academic medical center screens quality by manufacturer. Other providers protest: It’s not our job.
A prominent US health care provider who expressed frustration and dismay at a recent stakeholder workshop about prescribing generic drugs that don’t work, are recalled or sold out has gone to considerable lengths to protect patients from poor quality US-marketed drugs. Others, lacking the resources, have not.
Stakeholders found little comfort in assurances from US Food and Drug Administration officials at the Duke Margolis Center for Health...
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.
