FDA's new commissioner, Scott Gottlieb, is looking to go beyond the agency's ad hoc responses to sterile injectables drug shortages and find ways to prevent such shortages by stirring up more competition under Hatch-Waxman. Meanwhile, manufacturers are looking for deeper commitments from group purchasing organizations to buy such drugs, which would enable greater investments in facilities and equipment.
Shortages of five medicines used to resuscitate patients are the latest in a series of market failures that has FDA's new commissioner calling for manufacturing incentives to keep pharmaceutical supplies from flatlining.
Pfizer Inc. attributes the shortages to manufacturing, distribution and third-party delays at its recently acquired Hospira unit.
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.
