FDA will be issuing discipline review letters and information request letters to generic drug applicants to communicate shortcomings in ANDAs. Under GDUFA II, the US agency agreed to send out these letters at the mid-point of the review clock.
FDA Dec. 15 issued draft guidance explaining its procedures for issuing discipline review letters (DRLs) to communicate deficiencies found in abbreviated new drug applications as well as information request (IR) letters where information is lacking.
FDA agreed under the Generic Drug User Fee Amendments of 2017 to sending out these letters midway through the first...
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.
