Agency refrains from enforcing certain FD&C Act requirements against compounders who prepare alcohol-based hand sanitizers during COVID-19 public health emergency.
The US Food and Drug Administration announced on 14 March it will not enforce certain Food, Drug and Cosmetic Act provisions against compounders who prepare ethyl and isopropyl alcohol-based hand sanitizers to combat a shortage of these products during the COVID-19 crisis.
The agency will cheer on operations that might otherwise get sanctioned for marketing adulterated drugs because at least their products...
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.
