如上图所示,溶出方法可通过至少3个关键词直接查询,查询的结果包括装置、转速、介质、介质体积、取样点等信息,内容非常全面。 Drug Establishments Current Registration Site Search药品经营机构现行注册网站查询 Drug Safety-related Labeling Changes (SrLC) 药品安全相关标签变更(SrLC) Drug ...
Drug Establishments Current Registration Site Search药品经营机构现行注册网站查询 Drug Safety-related Labeling Changes (SrLC) 药品安全相关标签变更(SrLC) Drug Shortages药品短缺 Drugs@FDA Search药品@FDA搜索 已上市药品的信息可通过药品名称、原料药名称和申请号快速查询,也可通过药品的英文首字母和批准上市时间来分...
"We're hopeful this action will ensure patients have access to this important medication and provide additional peace-of-mind to parents as the agency works with the manufacturer to increase supply." Now, specific batches of 0.3 milligram products manufactured by Mylan may be...
” said Carl Reuterskiold, CEO of Qbtech. “We’re facing a global shortage of qualified clinicians to meet the growing demand for patients seeking help, not to mention the medication shortage that has been
prospect for patients," FDA Dr. Commissioner Margaret A. Hamburg said in a statement. "Through the collaborative work of FDA, industry and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need....
FDA published a final guidance to industry on establishing pregnancy exposure registries to provide clinically relevant human data that can be used in a product's labeling. I will work to build on these efforts to improve the availability of useful information about medication risks during pregnancy...
MedicationGuides(http:\/\/.fda.gov\/Drugs\/DrugSafety\/ucm085729.htm) DrugSafetyCommunications(http:\/\/.fda.gov\/Drugs\/DrugSafety\/ucm199082.htm) o DrugShortages(http:\/\...
The drug’s history and current pattern of abuse; The scope, duration, and significance of abuse; The risk, if any, to public health; The drug’s psychic or physiological dependence liability; and Whether the drug is an immediate precursor of a controlled substance.§ 811(c). ...
Despite these efforts, serious problems in manufacturing processes and in drug quality continued to plague the pharmaceutical industry, often leading to plant closures, product recalls, and drug shortages that compromised patient care. Patient deaths linked to contaminated heparin from China in 2008 and...
base of the syringe. At this time, FDA does not have information on how long drugs can be stored in these syringes before degrading. There is no information to suggest that there is a problem with potency or drug degradation when medication is administered promptly after the syringes are ...