An FDA guidance lists the criteria for reviewing “pre-submission facility correspondence” that permits expedited approval of priority generic drugs by allowing facility information to be reviewed prior to the submission of an ANDA. This mechanism was established by GDUFA II.
FDA took one step closer to speeding up generic drug application reviews by spelling out its criteria for reviewing “priority” generic drug applications. Under this mechanism, drug makers can have facility information reviewed before the submission of the application, thus shaving off application review time.
This mechanism, called the “pre-submission facility correspondence” or PFC, allows the agency to get some lead time in evaluating facilities...
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.
