Many of the six drug GMP warning letters the US FDA has issued since late March targeted lax testing practices, particularly at OTC firms abroad. Two EU GMP non-compliance notices highlighted data integrity shortcomings in India. FDA also posted a couple of Form 483 reports and added four facilities to its GMP import alert.
FDA sent a warning letter on April 19 to API maker Lijiang Yinghu Biochemical and Pharmaceutical Co. in Lijiang, a city in China's Yunnan Province, for their lax approach to computer access and for missing laboratory records.
For example, the laboratory equipment such as the high-performance chromatography (HPLC) and gas chromatography (GC) systems used to generate analytical data for batch release lacked restricted access
BioMarin’s ultra-rare disease drug Brineura has breached cost-effectiveness thresholds for highly specialized treatments in England and looks set to be denied routine funding on the National Health Service.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.
While drug companies say they support the European Medicines Agency’s expanded OPEN framework for the collaborative assessment of marketing applications with non-EU authorities, they are reluctant to participate in the initiative for a number of reasons.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.
At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.
