Senate Introduces Bill to Change OTC Monograph System

In August 2017, PDG published a paper entitled FDA OTC Monograph Changes Coming: User Fees, Pre-submission Meetings and Electronic Submissions. Although not included in the Food and Drug Administration Reauthorization Act (FDARA: included among others PDUFA VI/GDUFA II), the changes have emerged in Senate Bill 2315, introduced on January 17, 2018. CHPA reported “Today, the…

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Our Latest Paper Explains the Role of an FDA U.S. Agent

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, PDG routinely files…

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FDA Announces Public Workshop: FY 2018 Generic Drug Regulatory Science Initiatives

On May 24, 2018, “FDA will hold a public workshop that will provide an overview of the current status of the regulatory science initiatives for generic drugs and will provide an opportunity for public input on research priorities in these topic areas. FDA is seeking input from a variety of stakeholders—industry, academia, patient advocates, professional…

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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…

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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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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…

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