Global Drug Safety Updates from National Health Authorities

Recent Drug Safety Updates which included Signals, Product label updates, DHPC letters, etc.,

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Building Blocks [ICSR] in Drug Safety

Know the Basic fundamentals in Individual Case Safety Report (ICSR) - Case Processing in a Drug Safety Database

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PBRER Writing

Theoretical Guidance for writing a Periodic Benefit-Risk Evaluation Report (PBRER) - Know the fundamentals of presenting safety information in each section/subsections in PBRER

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DSUR writing

Theoretical Guidance for writing a Development Update Safety Report [DSUR] - Know the fundamentals of presenting safety information in each section/subsections in DSUR

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Recall of a Class I Medical Device: A most serious type recall

The announcement of recall and withdrawal of medicinal products and medical devices of class II and class III from market is considered usual. The recall scenario of a class I medical device due to serious injury to patient’s health is very rare and requires quite attention. Class I medical devices are “considered safe” which does not

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Medical device Vigilance system-USFDA requirements: a brief overview

Types of regulatory approvals: The following types of regulatory pathways are used for to avail USFDA approval for commercialization of a medical device into market. Premarket notification (510(k)): This regulatory pathway is a fast track system used for devices which do not require any clinical data and are substantially equivalent to a predicate device (similar

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Ranitidine drug status in India: Is it still used?

Ranitidine has an Indian market size of Rs 750 crore which is also commonly used OTC and prescription medicine by wide range of patients (pediatrics, adults and the elderly patients) commonly used for intestinal and stomach ulcers, Gastroesophageal Reflux Disease (GERD), esophagitis, Zollinger-Ellison syndrome etc., It is a H-2 blocking agent, which decreases the amount

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Drug Recall story of Ranitidine (An established drug since 3 decades)

A medicine having been considered as “Safe” since 1981 is recalled from the drug market. It’s not a surprise on recall of a drug from market which has an “assumed established safety profile”. Ranitidine, popularly known to public as Zantac, is a very common OTC (over the counter) drug and prescription stomach acid blocker widely

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The risk of skin cancer associated with Ingenol mebutate: Suspension of Ingenol mebutate use during PRAC review period.

Ingenol mebutate, which is commonly known as milkweed is indicated for the cutaneous treatment of non-hyperkeratotic, non‑hypertrophic actinic keratosis in adults.  The health authority of Ireland has cautioned patients and health care professionals on the use of this product in patients having history of skin cancer. It was reported in a randomized study results in

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Drug Safety: Aggregate reporting -An overview on types, regulatory timelines and requirements

The periodical reporting of aggregate safety reports to regulatory health authorities includes a comprehensive overview of the safety profile of medicinal product based on cumulative safety information accumulated by Marketing Authorization Holder (MAH). They also provide assurance that the MAH is continuously monitoring and critically assessing the benefit-risk profile of the product and taking appropriate

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Voluntary reporting of medicine side effects from Public

Spontaneous reporting of adverse effects/reactions/experiences of medicinal products is quite essential for generating the safety information of a medicine (for both new & well established medicinal products). Voluntary side effects reporting is a significant source for real world drug safety experience. A transparent benefit risk profile for a pharmaceutical medicinal product can be achieved through

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