In conjunction with NSW and QLD health, the Therapeutic Goods Administration (TGA) has investigated reports of counterfeit Alprazolam in community circulation. Testing of a number of products labelled ‘Alprazolam 2mg’ and ‘Kalma 2’ has found that: The Alprazolam 2mg product is an attempted counterfeit of a genuine product in the …
Once the company became aware of reportable incident the clock starts. If a death or serious injury has occurred it has to be reported between 2 and 10 calendar days (refer below table). Less serious events/incidents can be reported in 15 to 30 calendar days. If there is an incident …
The video include information on: Overview of the EU pharmacovigilance systems Risk management plans Eudravigilance and signal detection Periodic safety update reports
Glenmark’s Fabiflu is the first oral Favipiravir-approved medication for the treatment of COVID-19 and has been launched in few centers. The Drug Controller General of India approved the anti-viral for ‘restricted emergency use’ for treatment of mild to moderate cases, which accounts for a majority of COVID-19 infections. DCGI’s approval …
GSK Consumer Healthcare is voluntarily recalling to the retail level two lots of Children’s Robitussin® Honey Cough and Chest Congestion DM and one lot of Children’s Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups. During the review of the packaging documents for these products, GSK discovered …
The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after …
The ICH E2D guideline defines a spontaneous report as “an unsolicited communication by a health-care professional or consumer to a manufacturer, regulatory authority or other organization that describes one or more adverse drug reactions in a patient who was given one or more medicinal products and that does not derive …
It is widely accepted that there should be a method to separate medical devices into a small number of groups, or classes, and subsequently apply different conformity assessment techniques to each class. The global adoption of a rules-based classification procedure would offer significant benefits to manufacturers, users, patients, and regulatory …
Vaccines are considered drugs but require different immunization safety surveillance systems to monitor adverse events. Immunization safety is the process of ensuring and monitoring the safety of all aspects of immunization, including: vaccine quality, adverse events, vaccine storage and handling, vaccine administration, disposal of sharps, management of waste. The skills …
On Thursday, Roche announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorisation (EUA) for the Elecsys® IL-6 test. This test measures levels of the biomarker interleukin 6 (IL-6) and can be used to help identify patients with confirmed COVID-19 disease who could be at …
