Technology solutions for regulatory compliance

May 13, 2022 ... As the first and only FDA-approved GIP and GLP-1 receptor agonist ... While not indicated for weight loss, mean change in body weight was a key ... May 30, 2019 ... Does the FDA approve laboratories that test supplements? Tod ... What does "Contains a Bioengineered Food Ingredient" mean on the label of a ... May 6, 2024 ... IVD Definition Revised to Make Clear LDTs are Regulated Devices. Although the Federal Register notice announcing this monumental regulatory ... Note: Assignment of a registration number means only that the facility is registered. It does. NOT convey FDA approval or endorsement of the facility or its ... If a food facility did not register between that period, their prior registration has been invalidated by the FDA. Thus, a US Customs clearance rejection may ... Jun 17, 2024 ... Thus, as a result of this more narrow definition under MoCRA, cosmetic ingredient manufacturers or suppliers are not subject to registration and ... Mar 27, 2025 ... Registration only means that the FDA knows about the manufacturer and its connected health devices. When a manufacturer is “FDA-registered” or “ ... Jan 4, 2023 ... ... FDA showing comparable safety and effectiveness to the predicate device. In other words, substantial equivalence does not mean that the ... The FDA approves new drugs and certain biologics but these must be proven safe and effective to the FDA's satisfaction before companies can market them. If a virtual manufacturer does not have an FDA registration number but lists ... What does “readily retrievable” mean? “Readily retrievable” means that ...