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Wide range of food products, dietary supplements and other health foods that are consumed to enhance the nutritional value of food are constantly growing, worldwide. All combined can generally be termed as nutraceuticals. Global consumers are viewing the nutraceutical products as potential alternatives to medicinal products owing to their preventive characteristics against some of the common...
Be it a drug, device, cosmetic or food product, it is essential to convey the product information with respect to its usage, indications, warnings and other crucial aspects that are informative and beneficial to the end-user. As we all know, the primary source to communicate this information is the label on the package of a product, and additional components such as leaflets and inserts...
The Brazilian Association of personal hygiene, perfumery and cosmetics (ABIHPEC) announced a Regulatory revolution for the Brazilian cosmetics industry. The Health Surveillance Agency (ANVISA) has modified resolution RDC 07/2015 to simplify the regulations put on children products. The reformed resolution removes the obligation of registering the product before launching it into the market....
Registering a medical device with the FDA requires an apt submission pathway. In most of the cases, identifying and selecting a pathway is quite simple. For example, as discussed in our previous blog, if there exists a predicate for your medical device, then file a 510(k). If not or if your device is of...
In our earlier blog on US Food and Drug Administration’s (FDA) current thinking on post-approval changes, we discussed, what application types do the FDA’s industry guidance on post-approval changes to drug substances applies to and what types of changes does it emphasize. As there are multiple changes...
Do you know? The United States Food and Drugs Administration (US FDA) has yet again set a new record for the number of generic drug approvals. In comparison to FY 2017’s 937 approvals, FDA has approved a total of 971 generic drugs, so far this year which includes 781 final approvals and 190 tentative approvals. Out of the total approvals in this year, 12% were for complex...
In the current competitive landscape of Life Sciences, it is required to reduce the time-to-market for a quick product launch to take advantage of early success. For the same, manufacturers should ensure that all Regulatory aspects are adhered within the submission deadlines for successful approvals. If any observation is found by respective Health Authority in this entire process, it may lead...
Any modification to the drug substance manufacturing process such as facility / equipment changes, synthetic route changes etc. has the potential to affect the final drug product’s quality / efficacy / safety. To avoid such risks and keep the industry informed about the best practices, as part of the reauthorization of the Generic Drug User Fee Amendments (GDUFA II), the United States Food and...
Is it a right time to enhance the submission format for efficiency and consistency of Regulatory quality assessment? The outcome of recent discussions between USFDA (US Food and Drugs Administration) and the Pharmaceutical Science and Clinical Pharmacology Advisory suggests a positive sign. With the discussions, one can clearly make out that the FDA is exploring the positive aspects of...
Currently valued at $156 billion, the USA is the largest market for medical devices in the world representing approximately 40% of the global market. Given the scenario, manufacturers are on constant look out to market their products in the region. Enroute, even a small error in the approach can result a device recall. Therefore, it is necessary for the manufacturer to be at par with the...
North America
South America
East Europe
Europe
North Africa & Middle East
South Africa
APAC
Australia & New Zealand
Japan & South Korea
