A “predicate device” is a medical device that has been previously approved by the US Food and Drug Administration (US FDA) and is already on the market, which serves as a reference point for new medical devices seeking approval through the FDA’s …
- February 27, 2023 Medical Devices
- February 24, 2023 Regulatory Artwork Services, Regulatory Affairs
Manufacturing counterfeit and fraudulent items are highly profitable, particularly in the pharmaceutical industry. The illicit market for prescription medication has become a global menace, with patients' lives at risk as it continues to flood hospitals and pharmacies worldwide.
- February 24, 2023 Medical Devices
China is a major player in the medical device industry, and with its diverse population and expanding healthcare market, companies need to understand the necessary clinical trial requirements for medical device products in this region. The Chinese government has implemented a variety of regulations to ensure the safety and efficacy of medical devices being placed on the market.
- February 23, 2023 Regulatory Software & Services
Submission excellence can bring benefits to organizations and enhance the ability to launch products more quickly. It cuts short the delay in the process by simplifying and streamlining the organization’s ways of working.
- February 22, 2023 Pharmaceuticals, Regulatory Affairs
Latin America and the Caribbean (LAC) region is one of the world’s top emerging markets. Mexico, a part of the LAC, is full of opportunities, and expanding in Mexico can prove to be a game changer for global pharma manufacturers.
- February 22, 2023 Pharmaceuticals, Regulatory Affairs
Combination products are a distinct class of medical products created by physically or chemically combining two (02) or more regulated components (drugs, quasi-drugs, and medical devices) and producing them as a single unit.
- February 21, 2023 Food and Food Supplements, Regulatory Affairs
As per the regulation on Non-carbonated Water-based Beverages (Non-Alcoholic) released by the FSSAI on July 26, 2021, all FBOs were required to comply with the amended provisions by February 01, 2022. According to the amendment, “non-carbonated water-based beverages” (non-alcoholic) refer to drinks made with water that meet the requirements for packaged drinking water or mineral water but without adding carbon dioxide.
- February 17, 2023 Medical Devices
The primary distinction between a Unique Device Identifier (UDI) and a barcode in medical device labeling is that the UDI is a standardized identifying number assigned to each medical device, whereas a barcode is a graphic that can be scanned and read by a barcode…
- February 17, 2023 Publishing & Submissions, Regulatory Software & Services
China’s pharmaceutical industry has seen substantial growth since its entry into the World Trade Organization (WTO). As of 2021, China holds a 12% share of the global pharmaceutical market, making it the second largest contributor. According to Xinhua News Agency, the Chinese pharmaceuticals market generated 708.75 billion yuan in 2021, while the Chinese domestic medicinal companies amassed 502 billion USD in profit.
- February 9, 2023 Pharmaceuticals, Regulatory Affairs
New Chemical Entity (NCE) minus 1 filing, also known as a paragraph IV filing, is a type of application submitted to the U.S. Food and Drug Administration (FDA) for a new drug that is a slight variation of an existing drug. The minus 1 in the type of submission refers to the fact that the NCE is one small change away from an existing drug that has already been approved by the FDA and marketed under its surveillance.