If you are in the cosmetics industry, you know that navigating the Regulatory landscape can be challenging. Not only are there numerous regulations to follow, but there are also countless acronyms to learn. To help you better understand the world of cosmetic regulations, Freyr has put together a list of the most common acronyms you are likely to encounter while working in this industry. Provided below is a comprehensive list of the acronyms.
Electronic Labeling (e-labeling) is a medical device labeling alternative to traditional paper labeling. It entails the use of electronic media such as CD-ROMs, DVDs, or websites to provide consumers/users with label information. There are numerous benefits of e-labeling in the medical device industry. The most significant advantages are the following:
A 510(k) or a pre-market notification is a submission made to the United States Food and Drug Administration (US FDA) to demonstrate that the device to be marketed is safe and effective, that is, substantially equivalent to a legally marketed or a predicate device. The following are the three (03) types of 510(k) that a medical device manufacturer can submit:
After the United States Food and Drug Administration (US FDA)’s guidance document, titled ‘Integrated Summaries of Safety and Effectiveness (ISS/ISE): Location Within the Common Technical Document,’ was released in April 2009, the significance of Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) increased. ISS and ISE are pre-approval Regulatory submission documents for new drugs and biologics.
Audits and adherence to dynamic regulations have posed serious challenges for various pharmaceutical organizations. To list down the forthcomings of pharma audits, FDA warning letters and compliance adherence letters are endpoints, thereafter the compliance bridging is in the hands of pharmaceutical companies. Amongst such compliance letters, Form 483 issued by the US FDA remains frightening for any pharmaceutical establishment.
Post-approval change management is the process of monitoring and maintaining the safety, effectiveness, and performance of a medical device after it has received Regulatory approval and has been placed on the market. This process involves continuous evaluation and management of changes to the device, including changes to its design, labeling, manufacturing, and usage. The objective of post-approval management is to ensure that medical devices continue to meet Regulatory requirements and provide the intended benefits to patients and healthcare providers.
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. In the post-marketing phase of any pharmaceuticals or biologicals manufacturing company, budgets are mainly allocated to processes such as Adverse Drug Reaction (ADR) reporting and case processing, aggregate reporting, and signal detection.