Following the guidance in September 2020 on mitigating the risk of nitrosamine impurities in drug products, the United States Food and Drug Administration (USFDA) has recently suggested alternate approaches to reduce the formation of nitrosamine in certain products. According to the latest update, some methods can be incorporated by manufacturers for the prevention of such contaminations.
- February 17, 2022 Pharmaceuticals, Health Authority Updates
- February 16, 2022 Food and Food Supplements, Regulatory Affairs
On December 14, 2016, Health Canada published revisions to nutrition labeling, food color requirements, and the list of ingredients of the Food and Drug Regulations. The revisions intended to help Canadians easily understand the nutritional facts and list of ingredients to make informed choices. The major revisions include the following:
- February 16, 2022 Food and Food Supplements, Regulatory Affairs
The Food Safety and Standards Association of India (FSSAI) has recently announced new Regulations to amend the existing Food Safety and Standards (Import) Regulations, 2017. The Regulations came into force on November 06, 2021, and all the Food Business Operators (FBOs) must comply with all the Regulations from June 01, 2022.
- February 14, 2022 Medical Devices
With technological advancements, the adoption of wireless medical devices for patients and healthcare management is growing at a fast pace. It is anticipated that four (04) out of ten (10) medical devices installation will be wireless or portable by 2031, and the wireless portable medical device market is expected to reach USD 33 billion.
- February 4, 2022 Pharmaceuticals, Regulatory Affairs
A new report from a European generics trade association says that extreme cost-containment policies can adversely affect the generics supply chain vide consolidation of generics drug production and withdrawal of such products from the market.
- February 3, 2022 Biologicals, Pharmaceuticals
Over time, there have been huge developments in medicines and biologics sectors, and so have the changes in their respective Regulatory regimes and manufacturers’ responsibilities. On similar lines, recently, the TGA issued guidance describing the responsibilities of manufacturers of medicines and biologics. It is a step-by-step guide for:
- January 27, 2022 Medical Devices
The Medical Device industry is booming, with new technologies emerging every other day. The year 2021, like 2020, has experienced continued disruption owing to subsequent waves of the COVID-19 pandemic. However, the MedTech industry and its regulations have been changing steadily and adapted to all the changes swiftly to ensure all requirements laid down by the Agencies are met within timelines.
- January 7, 2022 Regulatory Software & Services
The post-pandemic world is realizing that the intersection of technology and a traditional way of doing business already exists with us. The highly competitive nature of our business only exemplifies the need of incorporating innovative technologies to augment and support customers in the ever-evolving Regulatory landscape.
Thanks to the rapid development of vaccines and quick vaccinations in major parts of the world, there seem positive developments in all the business sectors towards the growth. However, the threat is persisting in terms of new waves and new variants of COVID. Let us hope we soon get over this and see the brighter side of the business.
It is apparent that COVID-19 has permanently changed the ways of business operations for many industries across the globe. In fact, it has subtly given a renewed purpose to industries to evolve and advance in terms of tech-enabled and automated workflows.