Drug Safety Communication (FDA) – Risk of serious heart-related problems and cancer (tofacitinib) On 04 Feb 2021, the U.S. Food and Drug […]
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GVP Module XVI Addendum II – Methods for effectiveness evaluation (Draft for Public Consultation)
On 01 Feb 2021, EMA has released a draft Regulatory and procedural guideline on “GVP Module XVI Addendum II – Methods for […]
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GVP Module XVI – Risk minimisation measures (Draft for Public Consultation)
On 01 Feb 2021, EMA has released draft Regulatory and procedural guideline on “GVP Module XVI – Risk minimisation measures: selection of […]
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Safety signal (Risk of acute adrenal insufficiency) Hydrocortisone
European Medicines Agency (EMA) has published Direct healthcare professional communications (DHPC) regarding the Risk of acute adrenal insufficiency when switching from crushed […]
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Health Canada Open Consultation for Pharmacovigilance Professionals
Health Canada Open Consultation for Pharmacovigilance Professionals Health Canada announced a 90-day consultation for the revised guidance draft document: Reporting adverse reactions […]
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Adverse drug reactions
Definition of Adverse drug reaction Adverse drug reactions (ADR’s) are an important clinical problem. According to a World Health Organization (WHO), an […]
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V-safe
After Vaccination Health Checker – V-safe Centers for Disease Control and Prevention (CDC) has launched “V-safe” health screening tool to assist COVID-19 […]
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Free Online Vaccine Pharmacovigilance Course
Here we are going to give the best Free Online Vaccine Pharmacovigilance Course details. Vaccine Pharmacovigilance is defined as the science and […]
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FDA Approved Drugs December 2020
Here you can find FDA Approved Drugs in December 2020 This report includes NDAs, BLAs, ANDAs, approvals, and approved supplements to these […]
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USPI label updates December 2020
USPI label updates December 2020 The United States Prescription Information (USPI) is a key tool for sharing the benefits and risks of […]
