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Electronic Drug Registration and Listing (eDRLS) Lin Zhang
December 02, 2021
Last month (October 13, 2021), the Food and Drug Administration (FDA) held a conference that is part of the CDER Small Business & Industry Assistance (SBIA) Regulatory Education for Industry (REdI) series.
Electronic Drug Registration and Listing Instructions FDA
November 10, 2021
There are three steps, or submissions, that are needed to register an establishment and list a drug with FDA. Each of these steps requires an initial submission followed by periodic updates...
Two Products of Zhaoke Ophthalmology (6622.HK) Passed The On-Site Inspection for Drug Registration of The National Medical Products Administration and The GMP Compliance Inspection of The Guangdong Me prnasia
May 25, 2021
Zhaoke Ophthalmology Limited, an ophthalmic pharmaceutical company dedicated to the research, development and commercialization of therapies that address significant unmet medical needs, announced that on 13 May 2021, two pharmaceutical products of ...
Sirtex Medical and China Grand Pharmaceutical announce landmark drug registration milestone prnasia
August 27, 2020
The notice confirms that SIR-Spheres® Y-90 resin microspheres meet the relevant requirements for drug registration in China. With this confirmation, Sirtex is approved to file a New Drug Application (NDA) in the country.
Drug Registration Approval Granted for Sihuan Pharmaceutical's Pediatric Compound Amino Acid Injection (18AA-II) prnasia
March 23, 2020
Sihuan Pharmaceutical Holdings Group Ltd. (HKEX: 0460, "Sihuan Pharmaceutical" or the "Company", together with its subsidiaries, the "Group") is pleased to announce that drug registration approval has been granted by the National Medical Products Adminis