MicroPort receives CFDA approval for its EasyFinder steerable curve mapping catheter, enabling precise and effective diagnostic procedures in cardiac care.
FDA product approvals slumped last yearMedical Marketing & Media
Rubayo-Soneir - 2003 - 261-268 - www.sciencedirect.com This Letter deals with the stability of nonlinear Hamiltonian dynamics. The Jacobi–Levi–Civita equation for the geodesic spread is shown to be a powerful tool for the characterization of the so called Hamiltonian chaos. The special case...
Manufacturers of over-the-counter (OTC) drugs can choose to seek FDA approval through the NDA process or under what’s known as an OTC monograph. A monograph is described as a “recipe book” because it specifies the acceptable ingredients, formulations, labeling and testing parameters for more...
Without adequate documentation of analytical tests and equipment used, you lack basic data to support that each API product batch conforms to appropriate specifications before release and distribution. 如果没有足够的分析测试和所...
The Purvigor KN95 Mask, which your website indicates is manufactured by “Guangdong Fei Fan Mstar Technology Ltd.” (Guangdong), is offered for sale in the United States without marketing approval, clearance, or authorization from the FDA. Accordingly, the product is adulterated under section 501...
Ⅲ类器械产品(占7%左右),iii类产品为“上市前批准管理(pre-marketapproval,pma)”产品,是指具有较高风险或危害性,或是支持或维护生命的产品,例如人工心脏瓣膜、心脏起搏器、人工晶体、人工血管等。三类产品实施的是上市前许可,企业须向fda递交pma(premarketapplication)申请(小部分Ⅲ类产品可以走510k)。器械fda注册...
the root cause of releasing drug product prior to completion of all quality control testing was “due to the belief that such could be proceeded to next step with customer’s approval.” Additionally, you modified your standard operating procedure regarding the process for releasing drug product. ...
approval from FDA, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a), unless they are lawfully marketed under section 505G of the FD&C Act (which is not the case for this product, as further described below) or other exceptions not applicable here. No FDA-approved ...
Novel Drug Approvals for 2022FDA’s Center for Drug Evaluation and Research (CDER)New Molecular Entities (“NMEs”)Some of these products have never been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products that CDER approved in 2022....