The US FDA says it's working to provide the type of notice generic drug firms told the General Accountability Office they want to receive whenever the agency plans to issue or revise product-specific guidance on complex generics. Surprise issuance causes setbacks for generic drug sponsors who must scramble to revise their applications accordingly, if they can.
US FDA Commissioner Scott Gottlieb said Jan. 16 the agency is working to accommodate concerns generic drug firms have raised that they are often blindsided by new or revised product-specific guidance documents from the agency that can delay or even derail applications for approval of non-biological complex generic drugs.
The concerns surfaced in a Jan. 16 report from a congressional oversight agency, the General Accountability Office. The GAO
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.
