Search results
Results from the WOW.Com Content Network
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
Returned to market in 2017. [25] Glafenine: 1984 France, Germany Anaphylaxis. [3] Grepafloxacin (Raxar) 1999 Withdrawn Germany, UK, US others Cardiac repolarization; QT interval prolongation. [2] Hydromorphone (Palladone, extended release version) 2005 High risk of accidental overdose when extended release version (Palladone) administered with ...
Draft laws, regulations and rules and policy plans on the administration and supervision of food (including food additives and health food, the same below) safety, drugs (including traditional Chinese medicines and ethno-medicines, the same below), medical devices and cosmetics; formulate normative documents, and facilitate the establishment and implementation of the food safety responsibility ...
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
In December 2014, the Senate approved a bill that would add the Ebola virus to the Priority Review Voucher List. [23] The bill, S. 2917—Adding Ebola to the FDA Priority Review Voucher Program Act, was introduced by Senator Tom Harkin on November 12, 2014. President Obama signed it on December 16, and it became Public Law 113-233. [24]
The FDA granted 510(k) clearance for ClearPoint Neuro Inc's (NASDAQ: CLPT) version 2.1 of the ClearPoint Neuro Navigation software. Version 2.1 of the ClearPoint System is intended to provide ...
Stratafix knotless tissue devices [22] Surgicel absorbable hemostats [23] Monarch platform [24] [25] [26] Breast augmentation and reconstruction MemoryGel Breast Implants [27] MemoryShape Breast Implants [28] [29] Artoura Breast Tissue Expanders [30] CPX Breast Tissue Expenders [31] Mentor Saline Breast Implants [32] Eye health (Johnson ...