FDA Issues Draft Guidance on Development of Drugs for Rare Pediatric Diseases

“FDA draft guidance proposes collaborative approach to facilitate development of drugs for rare pediatric diseases… On December 6, 2017, the FDA issued draft guidance outlining a potential novel approach to develop new drug therapies for rare pediatric diseases. While Gaucher disease is the focus of the draft guidance, the purpose of the guidance is to facilitate drug development…

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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 505(j) or 505(b)(2) submissions), any workshop that includes discussion of new methods for characterizing and demonstrating equivalence tends to get our attention. CDER/OGD will be hosting Generic Orally Inhaled and Nasal Drug Products Workshop on January 9,…

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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 “The European Medicines Agency (EMA) has launched today a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). The…

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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 Voice by Scott Gottlieb, M.D.: “Early in the coming year, FDA’s Center for Devices and Radiological Health (CDRH) intends to advance several important new regulatory policy initiatives to further modernize the medical devices program and continue to foster new medtech innovation…” Cited were…

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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 week laid out a six-part roadmap to help the agency better evaluate new methodologies and technologies for their potential to expand FDA’s toxicology predictive capabilities and to potentially reduce the use of animal testing… The six-part framework…

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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 today approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better…

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