As a continuation of FDA Communications: Part I, this article will discuss the other two major types of communications with the FDA that were not discussed in Part I. As a reminder, there are four major types of communications with the FDA: Administrative meetings and communications Regulatory communications Product application meetings Public administrative proceedings This…
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As a company, the modern Pharmacy Office needs to know in depth both the state of your business and its environment, to improve your level of Strategic and Commercial Management. How can you achieve this? With the accompaniment of a specialized Consultant, to guide you through the complicated path to business success. But what features…
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The pharmaceutical industry is one of the sectors that grow year after year globally. Although it is an indispensable industry to maintain the health of the population, the right to which every human being has, it is also an industry like any other that has the right to obtain economic benefits, which allow it to continue working…
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In scientific writing, readers must find enough information to analyze the observations, repeat the experiments and evaluate the processes that led to their research and to achieve this author must keep in mind that the goal is to effectively communicate the result of the research. Keeping in mind the three basic principles of scientific writing…
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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…
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