PhRMA Takes on Congress’ Proposed Changes to Medicare Part D

FiercePharma, Thursday, February 15: “Pharma unleashes lobbying power to fight surprising—and costly—changes to Medicare Part D Pharma only recently suffered in Congress’ shutdown-averting spending deal, which put the industry on the hook for bigger discounts in the Medicare Part D coverage gap, but its advocates in Washington are acting fast to try to reverse the…

Details
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,…

Details

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…

Details

Healthcare Systems Plan To Make Their Own Drugs

January 18, 2018, John Nosta reports in Forbes that “Today, Intermountain Healthcare announced a bold initiative to establish a not-for-profit generic drug company aimed at ending shortages and reducing prices. Intermountain Healthcare is leading a collaboration with Ascension, SSM Health, and Trinity Health, in consultation with the U.S. Department of Veterans Affairs, to form the…

Details

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…

Details