DOJ Finalizes Expanded DEA Anti-Diversion Powers
The Justice Department issued a final rule Wednesday that will strengthen the Drug Enforcement Administration’s ability to crack down on drug diversion. Source: Drug Industry Daily
FDA Releases New Draft Guidances on Gene Therapies
The FDA unveiled six new draft guidances outlining its latest thinking on the rapidly evolving field of gene therapy — and Commissioner Scott Gottlieb said the agency plans to work…
Survey Shows U.S. Trust in Pharma Plummets Amid Rising Prices
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
FDA Issues Final Guidance for ANDA Amendments Under GDUFA II
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
FDA Issues Two Guidances on Payor Communications, Non-Label Information
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
FDA Issues Advice on Limited Population Pathway for Antimicrobials
The FDA released draft guidance for sponsors who want to use the agency’s limited population pathway for antibacterial and antifungal drugs.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
EMA, FDA Officials Discuss Mutual Recognition, Generics
Representatives from the FDA and the European Medicines Agency discussed further opportunities for collaboration in their 2018 annual meeting. Source: International Pharmaceutical Regulatory Monitor
EMA Proposes Single Clinical Guide for Bacterial Infection Treatments
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…
FDA Reports Challenging Year for Drug Shortages
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:…
TGA Adjusts Shortage Reporting Window Based on Feedback
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
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