Meta-analysis is a subset of systematic reviews that combines pertinent qualitative and quantitative study data from several selected studies to develop a single conclusion with greater statistical power. This conclusion is statistically more significant than the analysis of any single research due to the increased numbers of subjects, greater diversity among subjects, or accumulated effects and results.
- March 9, 2023 Regulatory Contract Staffing, Regulatory Affairs, Regulatory Consulting
Are high-interest rates, rising inflation, and unpredictable economic climate influencing your organization’s downturn? According to one of the reports, the medical science industry will necessitate seventy thousand (70,000) Regulatory roles over the next decade. Filling these positions has been and will continue to be a challenge for the industry.
- March 9, 2023 Regulatory Affairs, Publishing & Submissions
The electronic Common Technical Document (eCTD) is an internationally recognized format for electronic submissions to Regulatory Agencies. The latest version of eCTD, eCTD 4.0, includes several new features and enhancements that can help streamline the Regulatory submission process. However, adopting eCTD 4.0 can be challenging for organizations that are used to older versions or paper-based submission systems.
- March 3, 2023 Pharmacovigilance
Pharmacovigilance (PV) involves activities for detecting, assessing, understanding, and preventing adverse drug effects/adverse events (AE) of drug products to ensure the safety of the patients.
- March 1, 2023 Food and Food Supplements, Regulatory Affairs
The Food Safety and Standards Authority of India (FSSAI) has released comprehensive Regulatory standards to identify basmati rice. This is the first time in the country that FSSAI has come up with a regulation that will establish ethical trading standards for basmati rice, which will also safeguard consumers' interests both domestically and internationally.
- February 27, 2023 Medical Devices
Near-patient Testing (NPT) has the fastest-growing market in the IVD segment. Europe is the second-largest market after the United States for NPT. Many companies are trying to launch their NPT products in the European Union (EU), and now with the implementation of In Vitro Diagnostic Medical Device Regulation (EU IVDR) 2017/746, the companies are transitioning towards it.
- February 27, 2023 Medical Devices
One may think that placing a medical device on the market is the final step; however, even after the device’s launch, the manufacturer is required to fulfill the Post-Market Surveillance (PMS) requirements.
- February 27, 2023 Medical Devices
A medical device Regulatory strategy is a plan for ensuring that a medical device meets all relevant Regulatory requirements before it is marketed and used in clinical practice. This typically involves conducting pre-clinical and clinical testing to demonstrate the device's safety and effectiveness and submitting the results to Regulatory authorities for review and approval.
- February 27, 2023 Medical Devices
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 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.