Unmet Medical Need (UMN) is one of the most pressing priorities of health systems. Constantly evolving science and technology around healthcare has harbored the potential to explore various therapeutic options. Health Authorities encourage innovative therapies that promise significant benefits to patients' quality of life.
- June 1, 2022 Pharmaceuticals
- May 20, 2022 Publishing & Submissions, Health Authority Updates
Pharmaceutical advertising, including direct-to-consumer advertising, is regulated by the United States Food and Drug Administration’s (US FDA) Office of Prescription Drug Promotion (OPDP), Advertising and Promotional Labeling Branch (APLB) at the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER) respectively.
- May 19, 2022 Pharmacovigilance, Compliance, Audit and Validation, Regulatory Affairs
When the COVID-19 pandemic was first recognized as a global health crisis in 2020, global Health Authorities (HAs) took innovative steps to deal with it in the best possible manner. Likewise, pharmaceutical companies came up with several vaccines/medicinal products for the benefit of the public. However, registering the products turned out to be quite challenging.
- May 18, 2022 Food and Food Supplements, Regulatory Affairs
Food labeling claims in the USA can differ based on factors like types of claims, the product of interest, and usage. They are also different for animal food, human food, and dietary supplements. The regulations and scientific standards ensure the labeling claims for food and food supplements are mentioned correctly and substantiated scientifically.
- May 17, 2022 Compliance, Audit and Validation
In the wake of COVID-19, deploying remote audit techniques is rising in the Life Sciences industry. With the imposed travel restrictions across the globe, medical devices, biotech, pharmaceuticals, and other life sciences organizations are turning towards virtual or Remote audits. The remote audit is carried out by utilizing video conferencing auditor and auditee and other software/web applications.
- May 16, 2022 Medical Devices
Singapore’s Health Sciences Authority (HSA) has published a guidance document detailing the classification rules for In Vitro Diagnostic (IVD) medical devices. As per the general rule, Regulatory controls should be proportional to the level of risk associated with an IVD medical device.
- May 13, 2022 Cosmetics Regulatory Services, Regulatory Affairs, Regulatory Labeling
Health Canada regulates cosmetics sold in Canada. Manufacturers selling cosmetic products in Canada must ensure that their product labels comply with the labeling requirements. Cosmetic labeling includes various information, but one of the most important parts of the labeling is ingredient listing, which informs the customers about product composition.
- May 5, 2022 Medical Devices
Europe is the busiest region with evolving Regulatory landscape, as Brexit compliance, application of the EU MDR, transition to UKCA marking, and upcoming IVDR deadline take the front seat. All these dynamics have kept the Regulatory professionals on their toes. The UKCA mark came into effect on January 1, 2021, and the CE marked devices have a grace period until July 31, 2023, to eventually transition to the UKCA mark.
- April 28, 2022 Food and Food Supplements, Regulatory Affairs
Canada’s food regulations ensure they have one of the safest food supplies in the world. They are always looking forward to understanding and acting according to the changes or emerging trends in the food sector that may affect how or what they regulate. Currently, Health Canada (HC) is planning to consult with Canadians on modernizing the food regulations.
- April 28, 2022 Cosmetics Regulatory Services, Regulatory Affairs, Regulatory Labeling
Labeling is a vital aspect when it comes to marketing the cosmetic products as it helps consumers understand accurate details of the product. In Canada, cosmetics and personal care products are regulated by Health Canada (HC). Cosmetic labeling is regulated by the Food and Drugs Act, the Cosmetic Regulations, and the Consumer Packaging and Labeling Act and Regulations.