FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics


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Risk Management. US Regulations. FDA recognizes that a natural history study may provide an external control group for interventional trials if it is well-designed and conducted. However, natural history studies are subject to certain biases see Table 1 , which can limit their ability to demonstrate effectiveness.

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To mitigate bias, FDA notes that the treatment effect of the investigational drug should be dramatic. FDA distinguishes between two types of external controls: nonconcurrent and concurrent Figure 1. A natural history study completed before an interventional trial is classified as a nonconcurrent external control also commonly referred to as a historical control.

As noted above, natural history studies can play an important role in the development of rare disease therapies. Depending on the goal of the drug development program, the design of a natural history study can take on several forms. Retrospective studies are studies in which patient evaluations have already occurred. In contrast, prospective studies are studies in which evaluations occur in the future according to a prespecified data collection plan. In cross-sectional studies, data are collected from patients at a single point in time, which may be set by a stage of illness, date of diagnosis, onset of symptoms, or other criteria.

In longitudinal studies, data are collected from the same group of patients over a period of time. Data may have been collected at variable time points or were obtained inconsistently New data are generated after initiation of the study.

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Studies can follow standard operating procedures, which allows for greater consistency in the information collected Duration Studies can be performed quickly Studies generally require more time Medical terminology Medical terminology may have changed over time or have been used inconsistently among health care providers unclear use of terms may limit interpretability and result in incomplete information Studies can use up-to-date definitions of medical conditions and treatments Bias Can be biased through patient selection criteria and through selection of dates of inception and cutoff.

May be subjected to length-biased sampling patients who have been in the database the longest may be overrepresented Study evaluations occur in the future and are not highly susceptible to bias. Due to the limitations of retrospective studies, which may include inconsistent measurement procedures, irregular time intervals, and the unclear use of terms, retrospective natural history studies are more susceptible to bias than prospective natural history studies. These limitations may prevent such studies from being used as external controls if patient characteristics of an interventional trial cannot be matched with those of the historical control.

In contrast, prospective studies allow for the use of standard operating procedures and schedules so that data is collected consistently. Retrospective and prospective studies may be further classified as either cross-sectional or longitudinal. Table 2 summarizes the advantages of cross-sectional and longitudinal studies. While data from cross-sectional studies are less likely to be suited to be used as an external control group compared to longitudinal studies, cross-sectional natural history studies may provide valuable information for therapies intended to provide largely immediate benefits in patients experiencing an acute episode or flare of a disease.

In general, longitudinal studies provide more comprehensive information about disease onset and progression. It is important to note that while prospective, longitudinal natural history studies are desirable, the initiation of such studies should not delay a drug development program if interventional testing is ready to proceed for a serious disease with unmet medical need.

What are important considerations for the protocol, study design, data collection, and protection of human subjects in natural history studies? Below is a subset of the considerations for natural history studies noted in the guidance:. Apr 10 Mar 22 FDA Approvals , Neurology.


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By Greg Hileman, Ph. On March 5, the FDA approved Spravato esketamine nasal spray, for use in conjunction with an oral antidepressant for treatment-resistant depression.

Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by esketamine administration, and the potential for abuse and misuse of the drug, it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy REMS. Of importance to the development of products in the Division of Psychiatric Products DPP , the efficacy of esketamine was established in one short-term study two other, similar short-term trials did not meet the pre-specified statistical tests for demonstrating effectiveness and one longer-term maintenance-of-effect trial using a randomized withdrawal study design.

In this latter study, patients with a stable response while taking esketamine plus an oral antidepressant were re-randomized, with a portion of the group switched to placebo. Patients remaining on esketamine experienced a statistically significantly longer time to relapse of depressive symptoms than patients switched to placebo. This approval based on an enriched study design was one of the first for the DPP. Industry and FDA have long debated the utility of enriched study design as providing substantial evidence of efficacy.

The key issue identified by FDA statisticians is in controlling type 1 error with stepwise randomization schema and subsequently generalizing results from an enriched population to a general population as key. Various enrichment strategies have been proposed to address the large and growing placebo effect in psychiatry clinical trials.

FDA guidance on clinical trial designs encourages the exploration of enrichment and other adaptive study designs in Phase 2, but cautions against relying on such trials for generating pivotal evidence of efficacy. One can speculate that the approval of esketamine for depression may have political roots, since it allows FDA to exercise enforcement authority over the widespread off-label use of ketamine, now that seriously ill patients have a safe and effective approved product in this space.

We are optimistic that the approval of esketamine on the basis of this randomized withdrawal maintenance study may herald a new FDA attitude on the topic supported by incoming Acting Division Director Tiffany Farchione, whose first public appearance in that role was at the 12 February Psychiatric Products Advisory Committee Meeting reviewing esketamine.

In her opening remarks, Dr. The strength of these remarks bodes well for patients suffering a variety of psychiatric disorders where placebo effects have been attributed to the failure of clinical trial not only in depression, but also in anxiety disorders, schizophrenia and most conditions where structured patient interviews serve as the primary endpoints. Mar 20 Intravenous delivery i. Unlike these areas, effective regulatory professionals come from a variety of backgrounds; there is no one degree or career trajectory that promises success in the field. Successful regulatory affairs professionals typically have cross-functional training in areas such as science, pharmacy, engineering, marketing, and business.

Most of these individuals worked first in related industries, such as research and development, manufacturing, clinical research, lab sciences, pharmacology, and engineering. A majority of regulatory workers earn undergraduate degrees in the disciplines of life science, clinical science, public health, or engineering, but others begin in unrelated areas, such as business, economics, or liberal arts.

Regardless of your undergraduate focus, most prospective employers are more concerned with finding someone who possesses advanced regulatory knowledge and hands-on experience—two qualifications you can gain in a graduate program. Earning an advanced degree in regulatory affairs will not only make you more marketable to employers, but it will also yield career opportunities that might have otherwise been inaccessible.

According to Amato and Detwiler, there are several emerging trends influencing hiring patterns in the industry. These advances will likely expand the scope of work for regulatory professionals and shift employer demand toward new skills. Some of these trends include:. Amato says while regulatory job openings are abundant, companies are struggling to find the right level and combination of skills to fulfill their needs.

Fda Regulatory Affairs a Guide for Prescription Drugs Medical Devices and Biologics

Here are some suggestions for developing a competitive advantage to land the job:. The work of regulatory professionals is continuously shifting and expanding due to evolution in law, regulatory environments, technology, and global economics. Keep your regulatory knowledge base current by scanning multiple sources of regulatory affairs material daily to stay up-to-date on global changes in food and drug regulation.

Subscribing to updates from publications such as Food Safety Magazine or Medical Device Manufacturers Association can also provide you with industry-specific updates to help you stay relevant. Regulatory projects are usually complex, time-constrained, cross-functional, and resource-intensive.

Be proactive and focus on refining skills that complement this type of work, such as strong communication, critical and analytical thinking, negotiation techniques, project management methods, and a collaborative mindset. According to the report, 74 percent of U. Despite recent efforts to harmonize global regulations, many policies still diverge significantly. Regulatory professionals who can synthesize this information on a global scale to produce efficient, culturally agile programs will be highly valued.

Gaining an advanced degree in regulatory affairs is one way to gain this experience and help you translate knowledge into action. At Northeastern, students in the regulatory affairs program have the opportunity to work alongside faculty on short-term, real-world projects at leading organizations. Locate mentors embedded in the industry to help advance your career. Get involved with these groups to strengthen your network and get ahead.

The world of regulatory affairs is far-reaching and constantly evolving, making it a dynamic choice for a career. As always, there are several key considerations you should explore in order to determine if a career in regulatory affairs is right for you. Most importantly, you should evaluate both your personal and professional goals to better understand how a career in regulatory affairs can help you meet your goals.

Earning an advanced degree in a related field of study can prepare you for this competitive and in-demand career. Privacy Policy. Return to Blog Homepage.

FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics
FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics
FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics
FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics
FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics

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