FDA wants feedback on a proposal to standardize the data elements of the quality and chemistry, manufacturing and controls portions of applications. The agency says such a plan will enable consistency in the content and format of CMC data submitted, thus providing a consistent look and feel for every application.
US FDA said Aug. 22 it wants to hold a public meeting in October on an initiative to streamline the electronic submission of chemistry, manufacturing and controls information in new drug applications using standardized data elements the agency is developing.
The Oct. 19 meeting will provide the pharmaceutical industry an opportunity to discus concerns some industry groups and companies have...
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.
