What is an FDA U.S. Agent?

What is an FDA U.S. Agent?

February 2, 2018: PDG® is a global pharmaceutical consulting firm with extensive experience in the strategic development of drug products, biologics, medical devices, combination products and in FDA regulatory affairs. As such, PDG is an integral part of client decision-making processes with regard to the designation of FDA U.S. Agents and Official Contacts. In addition,…

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Drugs Going Off Patent in 2018

January 12, 2018, Juliette Preston reports in MedCity News “…here’s a round-up of prescription drugs set to expire in 2018 — based on current information… The list began with the National Pharmaceutical Services (NPS) calendar of medications coming off-patent by 2022. This was cross-referenced with the FDA’s ‘Orange Book,’ which provides up-to-date information on the…

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FDA Issues Draft Guidance on Development of Drugs for Rare Pediatric Diseases

“FDA draft guidance proposes collaborative approach to facilitate development of drugs for rare pediatric diseases… On December 6, 2017, the FDA issued draft guidance outlining a potential novel approach to develop new drug therapies for rare pediatric diseases. While Gaucher disease is the focus of the draft guidance, the purpose of the guidance is to facilitate drug development…

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