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The FDA sent a full response letter to Sanofi sutimlimab rejecting its listing application
Time of Update: 2021-01-21
Compiled on November 14, the FDA issued a full response letter regarding the application for permission for Sanofi supplement C1s inhibitor Sutimlimab biologics.
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Receive two warning letters in a year? Compliance issues at KVK-Tech, a U.S. generic drugmaker
Time of Update: 2021-01-10
FDA inspectors found that the plant did not properly integrate co-enchantment peaks and failed to detect excess results (OOS) when testing impurities on fentanine hydrochloride capsules, a weight-loss drug.
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Fda sends full response letter! Novart's U.S. launch of the heavyweight RNAi lipid-lowering drug has been delayed
Time of Update: 2021-01-02
production, and the FDA said it would not approve the drug's application for market until the issues found by the inspection were satisfactorily resolved. the FDA has not yet conducted on-site inspections of the plant, if on-site inspections
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Dongguan: a letter of warning on the implementation of special emission limits for atmospheric pollutants in the chemical industry.
Time of Update: 2020-10-19
Recently, Dongguan issued on the chemical, non-ferrous metal smelting industry to implement the special emission limits of atmospheric pollutants prompt notification letter. Details are as follows: Tips on the implementation of special
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More than 10% of pharmacies will adopt the "Internet plus regulation" model, according to a letter issued by the Fda.
Time of Update: 2020-08-06
on the Pilot Work of the Construction of the "Sunshine Pharmacy" Project (hereinafter referred to as the "Notice"). Notice shows that in order to effectively promote the modernization of the drug regulatory system and regulatory capacity
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FDA warning letter: dissolved non-conforming can not just modify the standard.
Time of Update: 2020-08-02
one of the company's capsule products in the stability study and sample inspection period, there have been multiple batches of dissolved test failure results.
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The FDA has sent four warning letters against Chinese medicine, including even flower-clearing capsules.
Time of Update: 2020-07-23
FDA said it has been observed that Chinese medicine (TCM) products sold in the U.S. are available on the site to alleviate, prevent, treat, diagnose or cure COVID-19.
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The Fda re-issued a letter - strengthen the mandatory industry standard management of medical devices.
Time of Update: 2020-07-22
Text . . . On July 9, the State Drug Administration issued a notice on matters related to further strengthening the management of mandatory industry standards for medical devices, and detailed the legal status, standard system, drafting
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FDA issues warning letter involving lianhua-clearing capsules
Time of Update: 2020-07-15
On June 29, the FDA issued a warning letter saying that the website of SuperHealthGuard and Loyal Great International Ltd., a company based in Hong Kong, China, could sell the co-op capsules to the United States, directly labeling the product
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FDA Safety Warning: Evista Increases Risk of Stroke-Related Deaths
Time of Update: 2020-07-07
Compared to the placebo group, the trial group, which used reloxifen for an average of 5.6 years, increased the mortality rate due to stroke (deaths: 59 (1.2%) vs.
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FDA Safety Warning: Estradiol Increases Risk of Stroke, Deep Vein Thrombosis and Malignant Tumors
Time of Update: 2020-07-07
On July 25, , the Food Drug Administration (FDA) approved safety label corrections that showed 0.06 percent estroGel; Ascend Therapeutics, Inc. to increase the risk of stroke, deep vein thrombosis, endometrial cancer and breast
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FDA warns of caution over use of radiofrequency ablation meter to treat lung tumors
Time of Update: 2020-07-05
The patient's death may be related to the patient's choice, follow-up treatment, and the technology used in radiofrequency instruments, including placement and operation.
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FDA issued a letter, this big variety may face de-listing!
Time of Update: 2020-04-03
On April 1, the FDA issued a letter requiring manufacturers to immediately withdraw all prescriptions and OTC retintin drugs from the market, the reason for this action is that the FDA has determined that if some renitin products are stored
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Another Chinese company is warned by FDA!
Time of Update: 2020-01-16
According to the reporter from pharmaceutical intelligence media, Huai'an Zongheng Biotechnology Co., Ltd
received a warning letter from the FDA on January 9, which
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Another Chinese pharmaceutical company is warned by FDA
Time of Update: 2020-01-08
1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
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Another Chinese pharmaceutical company is warned by FDA
Time of Update: 2020-01-08
According to Yao Zhi's news reporter, Henan Kangdi Medical Equipment Co., Ltd
received a warning letter from FDA on December 3, 2019
Henan Kangdi Medical
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False propaganda can be fatal! FDA warning
Time of Update: 2019-12-13
However, those who use vivitrol to treat opioid dependence should be aware of the potential risks at the end of the dosing interval, after missed administration, or after discontinuation of vivitrol treatment.
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Shocked! Many warning letters of FDA are on the Internet, such as mylan, Xerox
Time of Update: 2019-11-14
Today, the FDA has sent out a series of warning letters, involving Indian pharmaceutical companies cadilla healthcare, swabplus and mylan
These companies are suspected
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Shocked! Many warning letters of FDA are linked to mylan and Xerox
Time of Update: 2019-11-14
Recently, the FDA has sent out several warning letters, involving Indian pharmaceutical companies cadilla healthcare, swabplus and mylan
These companies are suspected
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Another Chinese company is warned by FDA!
Time of Update: 2019-11-07
Yaozhi.com learned that Hubei Bingbing Pharmaceutical (Group) Co., Ltd
received a warning letter from FDA on October 3, in which it pointed out that in 2018, due
