Recall of a Class I Medical Device: IMAGER II 5F Angiographic Catheters

A serious type of recall for medical device class I has announced by FDA for the Boston Scientific Corporation IMAGER II 5F Angiographic Catheters. This class I device is used to provide a pathway to deliver contrast agents to blood vessels including carotid arteries during angiography. During the patient procedure preparation, potential for the catheter

New Medical Device Approval: iTind, a non-surgical device for treating Benign Prostatic Hyperplasia (BPH)

On 07-Apr-2020, Olympus announced the approval of its non-surgical medical device, iTind for the minimally invasive treatment of Benign Prostatic Hyperplasia (BPH). FDA has provided a De Novo classification for this product and classified it under Class II medical device category. It is a temporarily placed urethral opening system for symptoms of benign prostatic hyperplasia.

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

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

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

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

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

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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