Author: Nikita Angane

Health Canada released a new notification on requirements for companies intending to manufacture face shields during the pandemic. Face shields are considered personal protective equipment (PPE) that helps in preventing exposure to particulates that spreads infectious diseases. A face shield...

Drug facility pre-approval inspections are required to grant a complete response letter from the FDA to get a new drug application approved. FDA understands that some facilities which are located in regions impacted by COVID-19 may have some travel restrictions...

FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) released a list of regulatory science tools to help the industry in new product development. The Office of Science and Engineering Labs is a part...

As FDA begins to restart on-site inspections of domestic and foreign sites, Health Canada on the other hand has all of its on-site domestic and foreign inspections for drug good manufacturing practices postponed until further notice.1 However, Health Canada is using...

Hand sanitizers in Canada are regulated by the Natural and Non-Prescription Health Products Directorate (NNHPD). When the pandemic was at its peak, NNHPD released an interim guidance for expedited approval of hand sanitizers to help mitigate supply shortages. The expedited...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) is taking big steps to deal with the pandemic during the ongoing 11 months transition period granted for its hard exit from the EU. As part of its preparation, UK’s MHRA...

The EU Compliance and Enforcement Group (COEN) recently released a new guidance document that provides information to the industry on how to design their instructions for use for re-usable and re-sterilizable devices. This new guidance document explains the EC’s view...

The US Food and Drug Administration released a final rule to exempt additional product codes from the requirements of 510(k) submission. FDA believes that this exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs...

The International Medical Device Regulators Forum (IMDRF) has recently issued a final guidance document to outline its expectations around the regulatory landscape for personalized medical devices. This recent guidance document builds on the previous IMDRF document, ‘Definitions for Personalized Medical...