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Hispec innovative drugs to be included in the priority review
Time of Update: 2020-04-03
On January 19, 2020, SDA accepted the application for "general anesthesia induction" indication new drug (special approval procedure), and on January 22, 2020, it undertook the drug registration application submitted by the company.
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List of varieties of drug review and consultation meeting in April 2014
Time of Update: 2020-04-03
From April 17 to 18 this year, CDE organized and held the third annual drug review consultation meeting in 2014, and provided the catalog of drug review consultation meeting in April 2014.
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Pharma 3.1 chemical new drug biapenem enters the three in one review
Time of Update: 2020-04-03
According to the website of the State Food and Drug Administration (CFDA) on April 14, the production site inspection of biapenem for APIs and preparations for injection, a new
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Publicity of drug registration application to be included in the priority review procedure
Time of Update: 2020-04-03
If there is any objection during the publicity period, please fill in the appendix "objection form of drug registration application priority review varieties", and feed back to our center: wuq@cde.org.cn.
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Changshan pharmaceutical heavy weight chemical "daparin sodium injection" review process returned to normal
Time of Update: 2020-04-03
According to the website of the State Food and Drug Administration (CFDA) on March 31, the review status of the blockbuster drug "heparin sodium" bulk drug and injection
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On the benefits of book review in improving writing ability
Time of Update: 2020-04-03
I think the best book reviewer is Argentine writer Borges, who can condense a novel into a wonderful short story.
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Reading experience, extensive reading is difficult to write good book reviews
Time of Update: 2020-04-03
But in the first reading of Don Quixote, it is very difficult to write book reviews.
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Hengrui paclitaxel and Lizhu eprazole accelerate the review
Time of Update: 2020-04-03
On Friday (October 28), it released the announcement of drug registration application to be included in the priority review procedure, with 29 acceptance numbers getting the opportunity of priority review.
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Category list of drug review and consultation meeting in August 2015
Time of Update: 2020-04-03
Appendix: No. of the catalogue of drug evaluation consultation meeting in August 2015 no.
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CDE drug review report in October 2014
Time of Update: 2020-04-03
Abstract: jiagelijing from xuanzhu, Shandong Province, and sofosbuvir, a new therapeutic drug for hepatitis C from Gilead, a new class 1.1 new drug, were first reported by domestic
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Jingxin Pharmaceutical Co., Ltd. and xinlitai entered the three in one review on the same day
Time of Update: 2020-04-03
According to the new drug review process, after the completion of the three in one review, only the drug review center forms a report, submits CFDA for signature and other procedures.
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Haizheng pharmaceutical enri generic ambano completed the "three in one review
Time of Update: 2020-04-03
According to the review center of the State Food and drug administration, the "three in one review" of the recombinant human tumor necrosis factor receptor antibody fusion protein
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CDE publicizes the application of HCV drug registration to be included in the priority review procedure
Time of Update: 2020-04-03
Drug evaluation center of State Food and Drug Administration Appendix 1 of April 18, 2016: Drug registration application priority review approval variety objection form.doc
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In 2019, 123 drugs not listed in China won the priority review of dongyangguang, Shiyao, etc
Time of Update: 2020-02-25
In 2019, 123 drugs not listed in China will be included in the priority review and approval of the national drug review center, and the review types include new drug listing, import listing and clinical application.
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In 2019, 123 drugs not listed in China won the priority review of dongyangguang, Shiyao, etc
Time of Update: 2020-02-25
In 2019, 123 drugs not listed in China will be included in the priority review and approval of the national drug review center, and the review types include new drug listing, import listing and clinical application.
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7 varieties to get priority review
Time of Update: 2020-02-21
On February 20, CDE released a batch of priority review and approval lists to be included, including 7 heavyweight drugs including ciprofol emulsion injection, naproxen sodium tablets, tacrolimus granules, apartamide tablets, inhaled nitric oxide, atizumab injection, odm-201, etc.
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HER2 specific TKI of Seattle genetics is qualified for priority review
Time of Update: 2020-02-14
Today, Seattle genetics announced that the FDA has accepted its new drug application (NDA) for the treatment of unresectable locally advanced or metastatic HER2 positive breast cancer with trastuzumab and capecitabine.
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Bristol Myers Squibb car-t therapy qualified for priority review
Time of Update: 2020-02-14
Today, Bristol Myers Squibb (BMS) announced that the U.S
FDA has accepted its car-t therapy lisocabatagene targeting CD19 antigen Maraleucel (LISO CEL) is a biologicals
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Kit's car-t therapy is qualified for priority review
Time of Update: 2020-02-11
Today, kit, a subsidiary of Gilead Sciences, announced that the US FDA has accepted its biological product licensing application (BLA) for car-t therapy kte-x19 to treat patients with relapsed / refractory mantle cell lymphoma (MCL).
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Pfizer tafamidis listing application in China to be included in the priority review
Time of Update: 2020-02-05
On February 3, CDE official website showed that Pfizer chlorobenzoic acid soft capsule (tafamidis) was included in the planned priority review procedure according to four rare diseases in the priority review scope (II).
