Abstract:
BACKGROUND:According to 21 Code of Federal Regulation (CFR) Part 211, Over-the-Counter (OTC) drug manufacturers must establish and follow current good manufacturing practices (cGMP) to produce quality products while meeting regulatory standards. The warning letters issued by the U.S. Food and Drug Administration (FDA) reveal quality inadequacies that may impact the safety and effectiveness of these products. This study provides an analysis of warning letters and cited violations to identify the most common areas of quality issues and to understand the FDA's current thinking on regulatory expectations. METHODS:Warning letters between U.S. fiscal years (FY) 2015-2019 were analyzed by the following steps: extraction of CFR violations, categorization of violations, trend analysis of data, and interpretation of results. RESULTS:A total of 116 OTC warning letters and for comparison purposes 561 prescription (Rx) warning letters were analyzed in this study. OTC drug violations relating to product and process controls significantly increased, while violations relating to labeling decreased over the years. Despite these changes in violation numbers, the number of violations increased in most categories, highlighting a continual increase of quality inadequacies. CONCLUSION:The quality issues are mostly seen in cGMP violations specifically in the drug product, process, and laboratory controls. Most significant violation changes are also seen in drug product and process controls. The overall number of violations in OTC drugs has been increasing in the past 5 years and the analysis results provide a projection for continued increases in violations. Although this study provides an overall quality analysis of OTC warning letters and cited violations, more studies are required to understand the risk to consumers using OTC drug products due to the trends associated with these observations.
journal_name
Ther Innov Regul Scijournal_title
Therapeutic innovation & regulatory scienceauthors
Bai HK,Ahearn JD,Bartlett MGdoi
10.1007/s43441-020-00231-2subject
Has Abstractpub_date
2020-10-23 00:00:00eissn
2168-4790issn
2168-4804pii
10.1007/s43441-020-00231-2pub_type
杂志文章abstract:BACKGROUND:Prescription drug labeling is an authoritative source of information that guides the safe and effective use of approved medications. In many instances, however, labeling may fail to be updated as new information about drug efficacy emerges in the postmarket setting. When labeling becomes outdated, it loses i...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479018759662
更新日期:2018-11-01 00:00:00
abstract::The purpose of the present review is to summarize the current pediatric regulatory requirements and also the regulatory efforts that need to be taken for the potential benefits of safety and efficacy to the pediatric patients. The importance of pediatric regulations came into existence as adult physiological condition...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章,评审
doi:10.1007/s43441-019-00087-1
更新日期:2020-05-01 00:00:00
abstract:BACKGROUND:Contending with a continuously expanding volume and variety of clinical data poses challenges and opportunities for the industry and clinical data management organizations. METHODS:Tufts CSDD conducted an online survey aimed at further quantifying and understanding the magnitude and impact that expanded dat...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00213-4
更新日期:2020-09-14 00:00:00
abstract:BACKGROUND:Several regulatory guidelines recommend that assessments of endpoints supporting drug approval should be verifiable by applicants and the regulatory agencies to minimize the potential for bias. This becomes especially critical when assessments are not based on measurable data but are derived from the interpr...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479015580382
更新日期:2015-11-01 00:00:00
abstract:BACKGROUND:Self-management can be considered a way of dealing with oneself and relates to actions undertaken to create order, discipline, and control. The concept is closely linked to concepts of self-efficacy and self-regulation but can be distinguished from these. The Self-Management Self-Test (SMST) is a 5-item asse...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479019849879
更新日期:2019-07-14 00:00:00
abstract::Social media presents new challenges to the biopharmaceutical industry for conducting pharmacovigilance activities. The authors reviewed worldwide regulatory guidance documents related to monitoring of adverse events posted on social media sites and identified gaps in current regulatory definitions for pharmacovigilan...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479015587362
更新日期:2015-11-01 00:00:00
abstract::Biopharmaceutical medicines are complex molecules obtained from a living organism (plant or animal cells) and may contain components of a living organism using biotechnology. Biosimilars are closely similar to already approved biopharmaceutical products that could form a new generation of medicines that are available ...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章,评审
doi:10.1007/s43441-020-00112-8
更新日期:2020-09-01 00:00:00
abstract::TransCelerate BioPharma Inc developed a methodology based on the notion that shifting monitoring processes from an excessive concentration on source data verification to comprehensive risk-driven monitoring will increase efficiencies and enhance patient safety and data integrity while maintaining adherence to good cli...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479014546336
更新日期:2014-09-01 00:00:00
abstract::Agents indicated for cleansing of the colon as a preparation for colonoscopy (bowel preps) are among the most frequently prescribed drugs for otherwise healthy patients. Better bowel preparation has been shown to translate into higher adenoma detection rates. Therefore, safety and efficacy standards need to be high. C...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479015577868
更新日期:2015-09-01 00:00:00
abstract::This study aimed to determine the potentially severe chemical properties of drugs that can cause adverse drug reactions (ADRs) such as erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) by using a data mining method. The study data were extracted from the Adverse Event Repor...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/0092861512460759
更新日期:2013-03-01 00:00:00
abstract::The regulatory agencies all over the world have defined the pathway and regulations for the approval of simple small-molecule generics. In addition, the agencies are striving to form perspicuous regulatory frameworks for the approval of biosimilars. In this view, there are no defined regulations for the approval of co...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章,评审
doi:10.1007/s43441-020-00114-6
更新日期:2020-09-01 00:00:00
abstract:BACKGROUND:The coherence between the relationship of QTc and drug plasma concentration (this relationship is measured through the slope) and ICH E14 findings based on hundreds of QT study reports was studied. RESULTS:Based on ICH E14 analysis, our findings indicate that if the slope was not positive, in most cases (86...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479014563549
更新日期:2015-05-01 00:00:00
abstract::Much has changed in a relatively short period of time. There is a raging debate over the level of evidence expected to first introduce a treatment to patients based on smaller, more adaptive data sets. Some argue for less data followed by postapproval follow-up, others for more adaptive clinical trial designs and end-...
journal_title:Therapeutic innovation & regulatory science
pub_type: 社论
doi:10.1177/2168479018766887
更新日期:2018-07-01 00:00:00
abstract::When registering food supplements in Russia, restrictions on the labeling and consumer leaflet contents are tightly controlled by the regulatory agencies. Thus, misleading advertising is the most difficult problem with the turnover of these products if information in the commercials does not correspond to the informat...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章,评审
doi:10.1007/s43441-019-00043-z
更新日期:2020-01-01 00:00:00
abstract:BACKGROUND:The human papillomavirus (HPV) vaccine coverage is very low in Japan since the government suspended the active encouragement of the vaccination. We aimed to conduct a benefit-risk assessment of HPV vaccination and explore different consequent scenarios to identify potential improvements to the current Japane...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00189-1
更新日期:2021-01-01 00:00:00
abstract:BACKGROUND:Patients and health care professionals receive information about pharmaceutical companies through various sources, including but not limited to print media, social media, and electronic media. The objective of this research was to benchmark the sentiment of electronic newspaper media coverage between 2014 an...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-019-00048-8
更新日期:2020-01-01 00:00:00
abstract:BACKGROUND:Obtaining assent from children participating in clinical trials acknowledges autonomy and developmental ability to contribute to the consent process. This critical step in pediatric drug development remains poorly understood, with significant room for improving the clarity, efficiency, and implementation of ...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479017716490
更新日期:2018-01-01 00:00:00
abstract::Although much information is already available publically from information-sharing initiatives such as ClinicalTrials.gov, information about clinical programs is unstructured, inconsistent, and incomplete. Clinical research within bioscience companies, health care, academia, and governmental agencies could benefit fro...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479014539158
更新日期:2015-01-01 00:00:00
abstract::Recently, it is becoming increasingly difficult to develop innovative drugs. Thus, the role of regulatory science research in drug development and postmarketing settings has become more important. In this article, the authors discuss the roles of regulatory science research at the Pharmaceuticals and Medical Devices A...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479012469950
更新日期:2013-01-01 00:00:00
abstract:BACKGROUND:The number of original and supplemental ANDAs, BLAs, NDAs, and Biosimilars FDA drug/biologic approvals (Approvals) has risen dramatically in the recent years, incidentally, so has the number of issued FDA guidances (Guidances). It is hypothesized that if the structures of the two timeseries are similar and/o...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00123-5
更新日期:2020-09-01 00:00:00
abstract:BACKGROUND:This study compared the timing, regulatory marketing authorization decisions, and the final labeling for products submitted to Swissmedic to those submitted to European Medicines Agency (EMA) and the US Food & Drug Administration (FDA). METHODS:The Centre for Innovation in Regulatory Science (CIRS) conducte...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479016655841
更新日期:2016-11-01 00:00:00
abstract::In the current pharmaceutical regulatory environment, patients continue to benefit from great advances in medical care. Sophisticated regulatory review systems have also evolved to ensure that safe and effective medicines are approved. However, these systems are not optimized in all countries. Gaps in individual regul...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-019-00055-9
更新日期:2020-03-01 00:00:00
abstract:BACKGROUND:The FDA Patient-Focused Drug Development Initiative was launched to ensure the incorporation of the patient voice into drug development and evaluation. Since 2017, the FDA must publish a statement outlining patient experience data (PED) considered in the approval of new drugs. This study investigated the pre...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00244-x
更新日期:2020-11-23 00:00:00
abstract::A growing number of organizations-including pharmaceutical and biotechnology companies, foundations and associations-are routinely implementing patient advisory boards (PAB) given their high reported value for minimal relative investment. Organizations are typically implementing PABs to solicit patient voices and pers...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479017720475
更新日期:2018-07-01 00:00:00
abstract::Meta-analyses are increasingly influencing clinical practice, but significant methodological flaws have been reported. The purpose of this study was to evaluate the quality of search strategies utilized by anti-infective meta-analyses. The Embase database was searched for meta-analyses evaluating anti-infective drug t...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479013516774
更新日期:2014-05-01 00:00:00
abstract::Confirmation of efficacy in pediatric drug development has traditionally required large, fully powered efficacy studies that have proven to have major feasibility and ethical challenges. Extrapolation of efficacy in the framework provided by the US Food and Drug Administration and European Medicines Agency is an appro...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479013500286
更新日期:2013-09-01 00:00:00
abstract:BACKGROUND:Safety data are continuously evaluated throughout the life cycle of a medical product to accurately assess and characterize the risks associated with the product. The knowledge about a medical product's safety profile continually evolves as safety data accumulate. METHODS:This paper discusses data sources a...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章,评审
doi:10.1177/2168479017741112
更新日期:2018-03-01 00:00:00
abstract::When does a single positive adequate and well-controlled study of a new drug meet the statutory requirement to demonstrate substantial evidence of effectiveness? The answer to this question, particularly with respect to new molecular entities, has been of considerable debate since 1962 when the requirement that new dr...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-019-00103-4
更新日期:2020-05-01 00:00:00
abstract:BACKGROUND:The US Food and Drug Administration (FDA) put out a call for comments on new draft guidance for industry "Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA." This call for comments elicited 7 submissions from various organization...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章,评审
doi:10.1177/2168479018775659
更新日期:2019-03-01 00:00:00
abstract:BACKGROUND:The design and sample size of a phase III study for new medical technologies were historically determined within the framework of frequentist hypothesis testing. Recently, drug development using predictive biomarkers, which can predict efficacy based on the status of biomarkers, has attracted attention, and ...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00119-1
更新日期:2020-09-01 00:00:00