Under the US FDA’s final MOU on interstate compounding, states are given more time to decide whether to sign the agreement and investigate complaints of adverse events associated with drugs compounded by 503A pharmacies. Agreement draws mixed reactions from pharmacy groups.
By keeping tabs on the number of compounded drugs going across state lines, states that sign a final memorandum of understanding (MOU) that the US Food and Drug Administration’s Center for Drug Evaluation and Research has published will help the agency ensure against uncontrolled distribution of compounded drugs.
The document, which was years in the making, establishes expectations for states to monitor out-of-state distribution of pharmacy-compounded drugs 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.
