International Pharmaceutical Regulatory Monitor

The European Medicines Agency expressed “serious concerns” about drugmakers’ preparedness for the UK’s departure from the European Union in a new report. Source: International Pharmaceutical Regulatory Monitor

The FDA unveiled new draft guidance on nonclinical testing of orally-inhaled drug products that contain nicotine — and Commissioner Scott Gottlieb said the agency plans to release follow-up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. Source: International Pharmaceutical Regulatory Monitor

Americans’ trust in drugmakers plunged in the past year to the lowest level since Edelman launched its annual Trust Barometer survey five years ago. Source: International Pharmaceutical Regulatory Monitor

The FDA released final guidance spelling out its review goals for amendments to abbreviated new drug applications and prior approval supplements under GDUFA II. Source: International Pharmaceutical Regulatory Monitor

The FDA published two final guidances clarifying the information drugmakers can provide to payors and what non-label information they can communicate. Source: International Pharmaceutical Regulatory Monitor

The FDA released draft guidance for sponsors who want to use the agency’s limited population pathway for antibacterial and antifungal drugs. Source: International Pharmaceutical Regulatory Monitor

Representatives from the FDA and the European Medicines Agency discussed further opportunities for collaboration in their 2018 annual meeting. Source: International Pharmaceutical Regulatory Monitor

The European Medicines Agency proposes to merge two guidances on clinical evaluations of bacterial infection treatments to reflect the latest scientific advice from its Committee for Medicinal Products for Human Use. Source: International Pharmaceutical Regulatory Monitor

In its fifth annual drug shortage report to Congress, the FDA called 2017 “a challenging year” with shortages up again from 2016 despite a steady overall improvement since 2011. Source: International Pharmaceutical Regulatory Monitor

Australia’s Therapeutic Goods Administration updated its plan for mandatory drug shortage reporting based on public comments in response to an April request. Source: International Pharmaceutical Regulatory Monitor