FDA Aims to Approve More Drugs Based on Early Clinical Data
(Reuters) – “The U.S. Food and Drug Administration is aiming to approve drugs based on very early data…
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FDA Issues Draft Guidance on Development of Drugs for Rare Pediatric Diseases
“FDA draft guidance proposes collaborative approach to facilitate development of drugs for rare pediatric diseases… On…
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FDA to Hold Workshop on Generic Orally Inhaled and Nasal Drug Products
Because we spend such a significant amount of our time on the development of complex drug products (whether…
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New EudraVigilance System Goes Live
Recently we reported EMA to Launch New Version of EudraVigilance. On November 22, 2017, EMA reported that…
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Gene-based Zika Vaccine Shows Promise in Phase I Trials
This is the tale of two stories: World Pharma News recently reported that “Results from two Phase 1…
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Commissioner Gottlieb Announces New Medical Device Initiatives for 2018
Advancing Policies to Promote Safe, Effective MedTech Innovation Posted on December 11, 2017 in FDA…
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RAPS Reports FDA Unveils Six-Part Toxicology Roadmap to Expand Predictive Capabilities
Regulatory Focus, Zachary Brennan, December 6, 2017: “The US Food and Drug Administration’s (FDA) Toxicology Working Group this…
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Trump Nominates Former Eli Lilly President Azar to Head HHS
November 26, 2017, the NY Times asks “He Raised Drug Prices at Eli Lilly. Can He Lower Them…
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BREXIT Update: After 22 Years, EMA to Leave London for Amsterdam
If you go to the EMA website and click “About us” you will read that “The European Medicines…
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FDA Approves First Implanted Lens Adjustable Post-cataract Surgery to Improve Vision
Sometimes we include a story because it’s simply fascinating:
November 22 – “The U.S. Food and Drug Administration…
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