After years of Mylan’s “one quality standard,” the merger with Pfizer Upjohn brings another. Which will prevail? Which should prevail?
A clash of quality systems looms at the as-yet unnamed venture announced 29 July that combines generics giant Mylan NV with Pfizer Inc.’s [Upjohn Laboratories] unit to treat non-communicable diseases of affluence spreading in emerging economies.
The venture will face the challenge of combining two quality systems, one rooted in generic drugs for developed markets and...
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.
