OMB Reviewing FDA Guidance On Nitrosamine Impurities

By Beth Wang, Beth Wang / August 11, 2020 at 5:39 PM
The White House is reviewing an FDA guidance on controlling the levels of nitrosamine impurities found in drugs, according to the Office of Management and Budget’s regulatory dashboard. OMB’s website doesn’t provide much information on the guidance, titled “Control of Nitrosamine Impurities in Human Drugs.” FDA told Inside Health Policy it didn’t have any public information to share, and OMB did not respond to IHP by press time. FDA has been investigating the presence of nitrosamines in heartburn...

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