How credible are the adverse drug events manufacturers receive?

Collecting adverse drug events from healthcare professionals and the public is mandatory for manufacturers. Minimum criteria apply to make such a case report valid. A valid case report must involve a suspect drug and a suspected adverse drug event, an identifiable patient, and an identifiable reporter. The ability to identify a reporter is essential to enable follow-up and avoid duplication of reports and fraud. The verification of the existence of the patient and a reporter is tricky for a variety

Read More »

Will pharmacogenomic testing become a routine part of clinical care?

Some adverse drug events are a predictable consequence of therapeutic, especially dosing failures. Idiosyncratic toxicities, on the other hand, are much less predictable and much more insidious. Pharmacogenomics is a powerful tool that can reveal some of these vulnerabilities before toxicity occurs or, if performed after the fact, can explain the cause of an adverse drug event that has already happened. Clinical trials cannot detect all adverse drug events due to the limited population in which the drugs are being

Read More »

Utilizing pharmacogenomic testing to ensure effective therapy

Some medications are administered as prodrugs that need to be metabolized in the active form by the body. An example of such a drug is codeine. It undergoes biotransformation into morphine by CYP2D6. Patients who transform codeine faster who are referred to as ultrarapid metabolizers, transform codeine into morphine so fast that they can develop opioid toxicity. On the other hand, poor metabolizers would not be able to produce enough active moiety, thereby making the drug ineffective. One such example

Read More »

Adverse incidents of medical devices

Medical Devices Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017/746 The new European legislation places numerous new obligations on manufacturers of medical devices marketed in Europe. The current requirements for reporting adverse incidents of medical devices in Europe are detailed in the Medical Devices Directive (MDD) [1], Active Implantable Medical Devices Directive (AIMD) [2] and In-Vitro Diagnostic Devices Directive (IVDD) [3]. The current procedures are described in Guidelines on a medical devices vigilance system [4]. The manufacturer is

Read More »

Meeting reporting obligations for medical devices

Medical Devices Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017/746 U.S. manufacturers of medical devices who are placing their devices on the European market have been facing many challenges relating to the new coming European legislation. The deadline for implementing the European Medical Devices Regulation (EU MDR 2017/745) and In Vitro Diagnostic Medical Devices Regulation (EU IVDR 2017/746) was postponed from May 2020 to May 2021 due to the COVID-19 outbreak, giving manufacturers more time to prepare. Manufacturers

Read More »

Supervised learning approach a necessary and important step in monitoring drug-related social media posts

Social media, such as Facebook and Twitter, provides many users with an outlet to share opinions online among a broad audience.  Some of these discussions concern their experiences with prescription and over-the-counter (OTC) medications.  These conversations can have an outsized influence on the public perception of the products they discuss.  The sentiment of individual posts regarding the efficacy and side effects of medications can be either positive or negative.  Consumers may also disclose misuse or abuse of the product.  Occasionally,

Read More »

COVID-19 Survey is now available in Spanish and Italian

To increase the reach, Veracuity LLC and Alliance for Clinical Research Excellence and Safety (ACRES) now offer the survey in multiple languages, including Italian and Spanish. TransPerfect Life Sciences, a leading provider for global development and commercialization of drugs, treatments, and devices, has generously donated translation services in support of these efforts. Healthcare providers or hospitals interested in completing the survey or contributing data to the initiative can do so at https://www.acresglobal.net/covid-19. The target audience for the survey is any

Read More »

Veracuity joins COVID-19 Evidence Accelerator

In April 2020, the Veracuity team developed a survey tool for the collection of data from hospitalized COVID19 patients. This initiative was implemented and widely distributed by the Alliance for Clinical Research Excellence and Safety (ACRES). At the recommendation of the Principal Deputy Commissioner of Food and Drugs, Amy P. Abernethy, M.D., Ph.D., Veracuity joined the COVID-19 Evidence Accelerator, organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research. The scarcity of evidence and ambiguity

Read More »

Subscribe to our newsletter