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An FDA advisory committee voted Tuesday in favor of the safety and effectiveness of Insmed’s NDA amikacin for treatment of nontubercuolous mycobacterial (NTM) lung disease for patients with limited treatment options. But the panel rejected it for adult patients as a whole. Read More
The FDA Tuesday finalized its recommendations on how drug sponsors submitting applications should control elemental impurities in their drug products. Read More
For a nonclinical toxicity assessment, the agency recommends that sponsors submit toxicity information for all components of the drug product formulation, heat-generated products and impurities. Read More
UK drug manufacturers will retain access to EU markets during the Brexit implementation period, the MHRA said in an update Monday, noting EU authorities will continue to recognize the UK’s manufacturing and distribution licenses as well as inspections. Read More
The FDA unveiled new draft guidance Monday on nonclinical testing of orally-inhaled drug products that contain nicotine — and Commissioner Scott Gottlieb said the agency plans to release follow-up guidelines later this year on potentially clinically relevant outcomes. Read More
Drug sponsors may not have to prove that a proposed medicine-assisted therapy helps addicts completely kick opioids but they will have to detail how well it helps cut dependence to win FDA approval, the agency says in a new draft guidance released Monday. Read More