Shifting from a One Drug Paradigm

Shifting from a One Drug Paradigm

A one-size-fits-all approach to drug therapy can be rather ineffective when treating today’s diseases. Pharmaceutical companies understand treating complex diseases such as cancer or HIV will require an effective combination of drug therapies. Combination drug product development offers significant therapeutic impact. Modern pharmacology recognizes that diseases are often multifactorial, consisting of a spectrum of medical…

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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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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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