The European Medicines Agency released a reflection paper to help guide generic drugmakers through the process of setting specifications for in vitro dissolution of immediate-release oral drugs. Source: Drug Industry…

The FDA will revise existing pre-submission draft guidance for ANDAs in light of the passage of the FDA Reauthorization Act of 2017. Source: Drug Industry Daily

The FDA cited a Montreal drugmaker for refusing to allow an FDA inspector to take photographs during an inspection — and said that alone can lead to a finding that…

FDA Commissioner Scott Gottlieb has elevated Rachel Sherman to the No. 2 job at the agency, principal deputy commissioner. Source: Drug Industry Daily