Hospital shortages of critical FDA-approved drugs used for treating COVID-19 patients has prompted the US FDA to loosen restrictions against compounding these drugs. In a related action, the FDA will now allow outsourcing facilities and compounding pharmacies to repackage propofol, also in short supply.
The US Food and Drug Administration has established temporary policies that allow pharmacies and outsourcing facilities to compound 13 drugs needed to treat patients hospitalized with COVID-19. Such discretion responds to the current shortage and demand for these drugs.
In a related action, the FDA also announced that it will permit outsourcing facilities and compounding pharmacies to repackage propofol,...
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.
