The US FDA’s FY 2020 budget request calls for funding to help advance the emerging drug compounding outsourcing sector, as did the FY 2019 request. The money would bring more training, specially tailored GMP requirements and a center of excellence.
An effort to use fiscal year 2019 federal funds to help establish a US outsourcing facility sector would continue next year under the Trump administration’s FY 2020 budget proposal, according to congressional budget justification documents.
The request includes $12m to “advance a new domestic drug industry and promote access by establishing the outsourcing facility sector...
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.
