On 30-October-2020, EMA had released detailed guidance on ICSRs in the context of COVID 19 – validity and coding of ICSRs. This detailed guidance document provides recommendations relevant to the processing and submission of Individual Case Safety Reports (ICSRs) associated with medicinal products used for the treatment or prevention of …
Adverse event following immunization (AEFI): any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the use of the vaccine. The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease. An AEFI that is caused or precipitated …
As per recent medical device safety information from MHRA, the Philips HeartStart MRx monitor/defibrillator therapy selector switch may fail, resulting in abnormal device behaviours including: the device may not perform the selected function the therapy knob may not change to the energy setting selected the device may deliver a shock …
The U.S. Food and Drug Administration released a Drug Safety Communication that it is requiring labeling changes for nonsteroidal anti-inflammatory drugs (NSAIDs). These changes include new labeling to explain that if women take the medications around 20 weeks or later in their pregnancy, the drugs can cause rare but serious kidney problems …
Health Canada released important safety information about health risks associated with the use of topical benzocaine products, including a rare but potentially serious blood condition known as methemoglobinemia (MetHb). As per communication Health Canada said they are continuesly receiving reports of benzocaine-related adverse reactions, including MetHb. The risk is higher …
The aim of pharmacovigilance is to protect and improve patient safety in relation to medicine. Pharmacovigilance detects problems related to use of medicine and communicate them in timely manner to regulatory authorities and healthcare professionals. The process can be devided into two parts. 1. Collection, assessment and reporting of adverse …
The U.S. Food and Drug Administration (FDA) has released drug safety communication about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl). Taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine diphenhydramine (Benadryl) can lead to serious heart problems, seizures, coma, or even death. In …
The majority of the SARS-CoV-2 vaccines are designed to induce immune responses to the spike protein. Expectations from vaccine include induction of neutralizing antibodies and T-cells to – mostly – the spike. Generally there are many types of vaccines, categorized by the antigen used in their preparation. Their formulations affect …
The new draft guidance from European Medicines Agency (EMA) aims to optimise the use of registry-based studies as a source of real-world evidence. The guideline’s primary focus is on the use of patient registries for studies by marketing authorisation applicants and holders (MAAs/MAHs). The guideline’s scope includes disease and condition …
Developing a vaccine takes a long time (usually 15 years). The general stages of the development cycle of a vaccine are: Exploratory stage Pre-clinical stage Clinical development Regulatory review and approval Manufacturing Quality control Different versions of vaccines will be created during exploratory stage and they are tested in iterative …
