Lack of readiness derails eye drugs from Valeant and Ocular, which now must convince FDA they know what they are making; meanwhile, an expert shares how mistake-proofing processes can help.
FDA's rejection of two applications for new eye drugs in the past week resulted from failures to demonstrate manufacturing readiness. Such failures are the most common reason for manufacturing-driven complete response letters (CRLs), agency investigators say.
In recent years, manufacturing issues accounted for at least one of every five CRLs, according to the Pink Sheet's FDA...
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.
