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.…
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…
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…
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…
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…
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…
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…
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…