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The FDA New Animal Drug Approval Process
Published in Rebecca A. Krimins, Learning from Disease in Pets, 2020
Jacob Michael Froehlich, Alice Ignaszewski, Anna O’Brien
A drug label provides the information necessary for the safe and effective use of the drug, which includes the indication(s), dosage, appropriate animal classes, warnings, and precautions, along with storage and disposal requirements. Depending on the drug, there may be numerous labeling components, including but not limited to the package insert, the immediate container label, any outer packaging such as the box or carton, and shipper labeling for multiple containers. The information on the drug labeling comes from studies submitted by the sponsor in the above-mentioned technical sections, as well as information known about the drug or drug class. This language is typically drafted during the evaluation of each technical section and the sponsor submits relevant portions of the labeling with each section.
Preclinical and Clinical Safety Assessment of Transdermal and Topical Dermatological Products
Published in Tapash K. Ghosh, Dermal Drug Delivery, 2020
Lindsey C. Yeh, Howard I. Maibach
The application of permeation enhancers in a transdermal or topical formulation may change the time course of clinical effects. Specific recommendations for the pharmacokinetic and biopharmaceutical data relevant to a new drug or new dosage form have been defined by the U.S. Food and Drug Administration (FDA) guidelines for the format and content of the human pharmacokinetics and bioavailability section of a New Drug Application (NDA). Further information concerning NDA efficacy documentation for a new transdermal formulation with penetration enhancement technology may also be obtained from the applicable reviewing division in the Center for Drug Evaluation and Research (CDER) at the FDA. The use of unapproved permeation enhancers may also call for an additional need to document safety in an NDA. TDD systems are regarded as a “new drug” within the meaning of the Federal Food, Drug, and Cosmetic Act, Section 200.31, and thus require submission of scientific data to substantiate their clinical safety and efficacy. Furthermore, all such drugs or controlled-release dosage forms must demonstrate their controlled-release characteristics to support drug labeling in accordance with FDA requirements.
Precision Medicine
Published in Paul Cerrato, John Halamka, Reinventing Clinical Decision Support, 2020
This type of program seems like a lifetime away for most physicians and patients who would benefit from PGx testing now. The US Food and Drug Administration publishes a list of more than 160 drugs that contain pharmacogenomic information in their package inserts. In the preface to the drug list, it states: “Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labeling may contain information on genomic biomarkers and can describe: Drug exposure and clinical response variabilityRisk for adverse eventsGenotype-specific dosing
Pharmacogenomics in the era of next generation sequencing – from byte to bedside
Published in Drug Metabolism Reviews, 2021
Laura E. Russell, Yitian Zhou, Ahmed A. Almousa, Jasleen K. Sodhi, Chukwunonso K. Nwabufo, Volker M. Lauschke
The benefits associated with the incorporation of pharmacogenomic studies in drug discovery and development can be attributed to technological advancements in the field of genomics including NGS (Dugger et al. 2018). The three main genomic approaches that have been applied in drug discovery and development include candidate gene studies, GWAS, and whole exome and whole genome sequencing (Burt and Dhillon 2013). These genomic studies have led to an increased body of knowledge regarding genetic polymorphisms associated with interindividual variation in drug response, which are commonly used by drug developers and physicians (Table 3). Additionally, the FDA provides a list of pharmacogenomic biomarkers in drug labeling (Table of Pharmacogenomic Biomarkers in Drug Labeling. FDA 2021), as well as other useful resources related to pharmacogenomics (Other FDA Resources Related to Pharmacogenomics. FDA 2021). This information gathered from several pharmacogenomic databases and evidence-based studies can help drug developers make critical decisions regarding (i) inclusion and exclusion criteria for drug targets, (ii) lead compound optimization (iii), recruitment of patient population for clinical trials and (iv) drug labeling.
Three-dimensional liver models: state of the art and their application for hepatotoxicity evaluation
Published in Critical Reviews in Toxicology, 2020
Xihui Zhang, Tianyan Jiang, Dandan Chen, Qi Wang, Leshuai W. Zhang
Adverse drug reaction (ADR) is the major cause of clinical trial failures and withdrawals of postmarked drugs. Drug-induced liver injury (DILI) is the one of the ADRs accounting for about 30% of the drug product withdrawn from the market (Stevens and Baker 2009). Accordingly, US FDA created a DILI Rank Dataset consisting of 1036 FDA approved drugs, which were further classified into four categories based on their DILI strength. The basis for drug classification came from the drug labeling documents, ADR reports, literatures and the logical relationship between the individual drug and the adverse effects (Chen et al. 2016). Therefore, it is emerging to evaluate and predict DILI during the early stages of the drug development, to reduce the time and cost on clinical trials of investigational drugs with DILI potential, which may ultimately be withdrawn in the postmarketing setting.
New safety signals assessed by the Pharmacovigilance Risk Assessment Committee at EU level in 2014–2017
Published in Expert Review of Clinical Pharmacology, 2018
Andrea Farcaş, Andreea Măhălean, Noémi Beátrix Bulik, Daniel Leucuta, Cristina Mogoșan
The most frequent PRAC recommendation for the 2014–2017 interval was a change in the product information. This is in line with PRAC recommendations from the previously analyzed period (2012–2013), when updating the SmPC was also the most common recommendation [12]. These results demonstrate the crucial role of PRAC in prioritizing and evaluating signals, ensuring that new or changed safety issues can be translated into product information updates for optimal, safe drug use. Similar decisions were also taken by the FDA as part of their post-marketing safety surveillance. In a 3-year time frame (2008–2010), label changes had occurred in 48% of the evaluated potential safety signals, the most common section adjusted being the ‘Warnings and Precautions’ section (62%) [26]. This was supported by another study that evaluated drug labeling changes proposed by FDA following safety issues in between 2010 and 2014, where the warnings (69%) and precautions (59%) sections were most often updated [27].