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Nov. 19, 2018

Vol. 17
No. 225


Gottlieb Highlights FDA’s Efforts to Hold Sponsors Accountable for Post-marketing Studies

FDA Commissioner Scott Gottlieb said the agency is committed to ensuring “timely completion” of post-marketing studies by drug sponsors in a Friday statement about the agency’s latest report on the status of reviews. Read More

Novartis Urges FDA to Flag Common Misconceptions About Biosimilars

Piggybacking on a petition from Pfizer, Novartis called on the FDA to debunk common myths about biosimilars and better educate consumers about their safety and efficacy. Read More

EMA Invites Comments on Water Quality Guideline for Drugmakers

The EMA is seeking stakeholder feedback on a draft guideline on the quality of water for pharmaceutical use. Read More

Pharma Group Calls for More Incentives for Antibiotic Research

International regulators need to take action to reverse the steep decline in research and development for antibiotics, according to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Read More