The FDA Drug Approval Process Improved

The FDA Drug Approval Process Improved

In 2018, the FDA pledged to improve the drug approval process and the efficiency of drug development, allowing pharmaceutical development consulting firms to serve their clients more effectively. In attempt to prevent drug shortages and to increase generic drug access, the FDA is improving their drug review process. Pharmaceutical development services can be expedited due…

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Regulatory Consulting- the Missing Piece to Your Puzzle

Regulatory Consulting- the Missing Piece to Your Puzzle

A trend of outsourcing regulatory affairs services has increased considerably. A lack of talented regulatory affairs professionals and stringent FDA regulations has contributed to the rising need for experienced FDA regulatory consultants. Pharmaceutical and device developers are focusing their energy in research and development operations while partnering with FDA regulatory consultants to provide regulatory affairs…

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Trump Budget Headlines Include Generic Exclusivity Changes; Medicare/Medicaid Savings

On February 8, 2018, Bloomberg Politics reported HHS Secretary Alex Azar’s announcement that “…he plans to take up the president’s promises to do something about pharmaceutical prices, targeting some of the U.S.’s costliest drugs with proposals to reduce patients’ out-of-pocket spending. ‘The president is firmly committed in this space,’ Health and Human Services Secretary Alex…

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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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