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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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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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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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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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Lafutidine, a new gastric ulcer drug of Changjiang Pharmaceutical Co., Ltd
Time of Update: 2020-04-03
According to the information on the website of the State Food and Drug Administration (CFDA) on August 6, the raw materials and tablets of lafutidine, a class 3.1 chemical drug
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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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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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The document issued by the State Food and Drug Administration provides guidance for the control of nitrosamine impurities
Time of Update: 2020-01-14
▍ source: State Food and Drug Administration ▍ sorting out: looking forward Recently, the State Food and Drug Administration issued a public consultation on the technical
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Jiayi medicine is expected to win the first imitation of sinacase hydrochloride
Time of Update: 2020-01-13
[January 13, 2019 / medical information list] the opinion draft of technical guidelines for research on nitroamine impurities in chemical drugs was released; in 2019, the cancer
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Nmpa issued technical guidelines for the study of nitrosamine impurities in chemicals for comments
Time of Update: 2020-01-13
Source: State Food and Drug Administration Recently, FDA announced three recall announcements of ranitidine in a row, and the problem of nitrosamine impurity was pushed to the air
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Heavyweight products recalled
Time of Update: 2020-01-12
Recently, three NDMA related recall notices have been released on the FDA website, involving drug companies such as mylan, Northwind and appco, and products such as nizatidine capsule, ranitidine tablet and ranitidine capsule.
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Wave after wave! Another problem with ranitidine, another drug company chose to recall
Time of Update: 2020-01-09
ANI Pharmaceuticals Inc., on behalf of Appco Pharma LLC, will be notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts.
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Paclitaxel injection of Huiyu pharmaceutical is to be included in the priority review
Time of Update: 2019-12-26
At present, Paclitaxel injection has not been evaluated by the enterprise, and Huiyu pharmaceutical has applied for production of new 4 categories of chemical drugs.
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Do you know six classic drug recalls
Time of Update: 2019-11-03
Photo source: Internet In more than four years of marketing, rofecoxib has reported nearly 28000 cases of cardiac death or heart disease.
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Top 10 hot varieties "accepted / passed" in conformity assessment
Time of Update: 2019-10-28
On the eve of the proposed consistency evaluation policy, the industry is guessing whether the policy will be implemented and discussing which enterprise some varieties
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Take stock of top 10 "accepted / passed" hot varieties in conformity evaluation
Time of Update: 2019-10-28
On the eve of the proposed consistency evaluation policy, the industry is guessing whether the policy will be implemented and discussing which enterprise some varieties
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Ranitidine's attitude towards banning doctors
Time of Update: 2019-10-23
Since the 2nd of this month, intermd, a knowledge sharing community of Korean doctors, has investigated 1021 doctors about the banning of ranitidine
The results show
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In 2019, the reform of drug review and approval continued to deepen. What are the achievements
Time of Update: 2019-10-18
It can be seen that with the improvement of China's innovation and R & D environment, the acceleration of examination and approval, and the growing pharmaceutical market, foreign pharmaceutical enterprises are deeply attracted.
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Risk of cancer! Sales of 8 kinds of gastric acid drugs stopped in Singapore
Time of Update: 2019-09-18
In a statement Monday, the Health Sciences Authority of Singapore said sales and supply of eight drugs had been suspended because they were found to contain an impurity called NDMA, linked to cancer.
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[good medicine record] consistency evaluation has been done over and over, 4 + 7 competitive products are hot, the second imported generic drug has successfully passed the test, potential varieties are strong
Time of Update: 2019-09-16
As of September 12, the acceptance number of CDE acceptance consistency evaluation reached 1419 (403 of 416 enterprises are calculated as supplementary applications, the same below
