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…
DetailsOn 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…
DetailsIn 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…
DetailsPDG® 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…
DetailsOn 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…
DetailsFiercePharma, 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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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,…
DetailsJanuary 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…
DetailsAs a pharmaceutical industry professional, you already know there are a bevy of different types and structures of clinical studies. However, you may need a resource to help you sort them all out. This paper includes a variety of categorical descriptions of types of studies, controls, designs, definitions and examples, including links to authoritative source material.…
DetailsAccording to CDER “Each year, CDER approves a wide range of new drugs and biological products. Some of these products are innovative new products that never before have been used in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. Certain…
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