Clinical Operations-Design to Execution

BayBiotech.NET As per definition of Office of Health and Safety, “containment" is a term used for describing safe methods for managing infectious materials in the laboratory environment where they are being handled or maintained. The main objective of containment is to reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially hazardous agents. Two levels of containment defined are Primary and Secondary containment. Whereas, primary containment refers to the protection of personnel and the immediate laboratory environment from the infectious agents, the secondary containment refers to the protection of the environment external to the laboratory from the exposure to the infectious agent/ material. Primary containment is provided by good microbiological techniques and use of appropriate safety equipments. Secondary containment is provided mainly by a combination of facility design and operational procedures. A combination of ri...

The legislation on the Medical Device User Fee Amendments of 2007 (MDUFA), is part of a larger bill — the Food and Drug Administration Amendments Act of 2007 (H.R. 3850) and according to this, a substantial reduction for all existing application fees have been proposed, while providing for new types of medical device user fees. The new user fees are proposed for: • Submission of a 30-day notice. • Submission of a 513(g) request for classification information. • An annual fee for periodic reporting on a class III device. • An annual fee for the registration of a medical device establishment that is a manufacturer, a single-use device reprocessor, or a specification developer. On the other hand all existing application fees are substantially reduced for PMA, Panel-track PMA Supplement, BLA Efficacy Supplement, as well as 510(k) Notification remarkably for small businesses in a range between -18 – 70%. Follow this link to read more on this: Medical Device User Fees Have Been Re...