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In this work, PET was long-chain branched with PMDA and tetrahydrophthalic acid diglycidyl ester (TADE) together by ring-opening reaction through reactive melt processing, in order to improve the mechanical toughness of PET by increasing its molecular weight and molecular entanglement.
To significantly improve their chances of market penetration, medtech firms should meet with the PMDA early for guidance on the clinical and economic evidence that is acceptable and necessary for regulatory approval.
Required by the United States Food and Drug Administration (FDA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by the world's leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data.
ReproCELL, our Japan partner, has also submitted its CTN to the PMDA to assess Stemchymal SCA in treating PolyQ SCA in Japan."
Following the direction of director general PMDA in this regard, he further said they have evolved future action of plan to hold seminars and awareness walk for sensitization of citizens.
Under the Plutonium Management and Disposition Agreement (PMDA), both countries committed to "dispose of no less than 34 metric tons of weapon-grade plutonium removed from their respective defense programs.
As a result of meetings with the Pharmaceuticals and Medical Devices Agency (PMDA), the application package submitted was not sufficient for approval, and therefore Eisai has withdrawn the application.
(STA), has received its first approval from the Japan PMDA for the manufacture of the GMP intermediate of a branded commercial drug.
The CFDA registered, FDA cleared, Health Canada licensed, CE marked, TGA, PMDA certified and MDCO certified mobile medical diagnosis software can be integrated into any EMR and easily plugs into existing distributed storage systems.
EirGen, situated in a high containment research and development, and manufacturing facility, is approved by the FDA, EMEA (European Health Authorities) and the PMDA (Japanese Health Authorities).
Also, current sales of the company's device NIOX MINO, that was launched in Japan in November 2013, has been above expectations and NIOX VERO now joins NIOX MINO as the only devices for FeNO measurements that are approved by PMDA for sale in Japan.
Table 1 and 2 show that there is significant difference observed among case v/s control in both the parameters (pmDA and s-SOD) and the same trend is seen when age wise and sex wise comparison was done among cases and control.
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