The stakes on Capitol Hill rose another notch as tornado hit supplies of sterile injectable drugs at North Carolina plant. Workers escaped serious injury by gathering in designated shelters; patients may need effective legislation to escape serious injury from drug shortages.
A tornado put an exclamation point on the debate in Washington over how to stop shortages of sterile injectable drugs when it touched down 4:43 pm Wednesday near Battleboro, NC, and tore through a warehouse at Pfizer Inc.’s Rocky Mount, NC, plant, scattering an estimated 50,000 pallets of finished sterile injectable drug products.
Workers scurried into designated shelters like the old gamma irradiation chamber next to the warehouse shortly before it was hit...
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.
