Drug developers have a daunting task when it comes to selecting the correct clinical trial design. Choosing the wrong clinical trial design can prolong the development time and create unnecessary expenses. It is important to explore the benefits for the different clinical trial design types, such as conventional clinical trial design and adaptive clinical trial…
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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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Over-the-counter (OTC) drug products are a billion-dollar industry consisting of over one hundred thousand OTC drugs marketed currently. OTC drugs also known as nonprescription drugs are not held in the same class as prescription drugs since they do not have high toxicity requiring practitioner supervision. Similar to prescription drugs, there are FDA drug labeling requirements…
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The FDA is comprised of multi-disciplinary experts in chemistry, microbiology, pharmacology, toxicology and other various disciplinaries. It is important to keep in mind that these are the experts that will review your pharmaceutical product development report and data. A key to an effective strategy for IND planning is to know the process for submission. The…
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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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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…
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