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In August 2020, the U.S. Food and Drug Administration (FDA) became aware of nitrosamine impurities in certain samples of rifampin. [61] The FDA and manufacturers are investigating the origin of these impurities in rifampin, and the agency is developing testing methods for regulators and industry to detect the 1-methyl-4-nitrosopiperazine (MNP ...
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
The rifamycin group includes the classic rifamycin drugs as well as the rifamycin derivatives rifampicin (or rifampin), rifabutin, rifapentine, rifalazil and rifaximin. Rifamycin, sold under the trade name Aemcolo, is approved in the United States for treatment of travelers' diarrhea in some circumstances. [1] [2] [3]
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
Management of tuberculosis refers to techniques and procedures utilized for treating tuberculosis (TB), or simply a treatment plan for TB.. The medical standard for active TB is a short course treatment involving a combination of isoniazid, rifampicin (also known as Rifampin), pyrazinamide, and ethambutol for the first two months.
Vietnamese Pharmaceutical Association (VPA, Vietnamese: Hội Dược học Việt Nam) is a voluntary social and professional association of pharmacists and pharmaceutical workers in Vietnam. [1] It is a member of the Vietnam Union of Science and Technology Associations .
The hope of a fixed-dose combination pill is to increase the likelihood that people will take all of three medications. [5] Also, if people forget to take one or two of their drugs, they might not then develop resistance to the remaining drugs.
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.