The US FDA makes it easier for local agencies to extend expiration dates for doxycyline used in emergency situations; more drug quality updates in this week's lowdown.
Clarity is the theme of this week’s quality lowdown – clarity on how it will be easier to extend shelf lives for certain drug products stockpiled for emergencies, on how drugs can be detained at the US border even if sometimes they are not actually drugs, and on why a veterinary anesthetic was recalled not over a pet’s death but for lack of clarity.
And although it was a quiet week on the enforcement front, there were some drug recalls of note. The valsartan...
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.
