An Introduction to Clinical Trials and Resources for Continued and Intermediate Learning

In January 2018 this introduction to clinical trials was prepared by the pharmaceutical consultants at PDG who routinely design and write clinical trial protocols. This paper represents a collection of quotes and resources ranging from basic primers to more advanced concepts. This is provided for drug and medical device professionals who may not serve in…

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FDA Issues Draft Guidance on Development of Drugs for Rare Pediatric Diseases

“FDA draft guidance proposes collaborative approach to facilitate development of drugs for rare pediatric diseases… On December 6, 2017, the FDA issued draft guidance outlining a potential novel approach to develop new drug therapies for rare pediatric diseases. While Gaucher disease is the focus of the draft guidance, the purpose of the guidance is to facilitate drug development…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