Coronavirus hysteria sweeps up languishing drug shortage legislation; prospects for new reporting and risk management planning requirements improve.
Bipartisan drug shortage legislation is gaining traction in the US as coronavirus outbreak begins disrupting the pharmaceutical supply chain: There is a new bill in the House and growing stakeholder support for both the House bill and companion legislation that had been languishing in the Senate.
Proponents hope to attach a final version of the drug shortage provision to health extenders legislation that must pass for...
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.
