The European Medicines Agency (EMA) and the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) have completed preliminary reviews of the risk of blood clots in people vaccinated with the AstraZeneca COVID-19 vaccine. These reviews have found the benefits of the vaccine continue to outweigh the risks, and …
India’s Central Drugs Standard Control Organisation (CDSCO) has released a notice informing sponsors that they are required to file Serious Adverse Event (SAE) reports electronically via the Sugam online portal from 14 March 2021. Following the Indian government’s implementation of The New Drugs and Clinical Trials Rules, 2019, SAEs are …
As per Guidance document on MvPI, Severity of an adverse event was broadly classified into three categories. Death of a patient, user of the device or other person Serious injury to a patient, user or other person – Serious Injury (also known as serious deterioration in state of health) is …
The MvPI reportable adverse events include but are not limited to: A malfunction or deterioration in the characteristics or performance of the medical device An incorrect or out-of-specification test result The discovery of a design flaw during design review An inaccuracy in labeling, instructions for use and/or promotional materials.Inaccuracies include …
During a global emergency, making clever use of existing resources is a fundamental human impulse. But, the cavalier repurposing of hydroxychloroquine, chloroquine, and azithromycin during the COVID-19 pandemic has consequences. Seven deaths from cardiac adverse events occurred with the off-label use of drugs whose power to prevent COVID-19 has been …
Based on the concerns raised by the drug authorities, the Danish Health and Medicines Authority has, based on a precautionary principle, chosen to pause vaccination with the COVID-19 vaccine from AstraZeneca. The break lasts so far for 14 days, and the Danish Health and Medicines Authority, together with the Danish Medicines …
Regulation of Medical devices in India The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services in Ministry of Health and Family Welfare (MoHFW), Government of India (GoI) is the National Regulatory Authority (NRA) responsible for approval of manufacturing, import, conduct of clinical trials, laying down standards, …
The Federal Office for Safety in Health Care (BASG) has received two reports in temporal connection with a vaccination from the same batch (ABV 5300) of the AstraZeneca vaccine in the district of Zwettl (Austria): a woman (49 y) died as a result of severe coagulation disorders, another woman (35 …
Xeljanz with active ingredient of Tofacitinib is used to treat certain types of arthritis (such as psoriatic arthritis, rheumatoid arthritis, polyarticular course juvenile idiopathic arthritis-pcJIA). It helps to decrease pain/tenderness/swelling in the joints. Tofacitinib is also used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach …
Merck & Co. will withdraw Keytruda in small-cell lung cancer, or SCLC, in the U.S. roughly a year after a confirmatory trial showed the immunotherapy, when added to chemotherapy, didn’t help patients live longer than chemo alone. The Food and Drug Administration granted accelerated approval to Keytruda in SCLC in 2019 based on its …