[1].https://www.cnbc.com/2023/06/02/cancer-drug-shortage-fda-allows-import-of-unapproved-china-chemo-med.html [2].https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Cisplatin%20Injection&st=c&tab=ta...
OND官网提供与新药审评及其相关的信息查询工具主要包括“Drugs@FDA Database”、“Drug Application and Approval Process - "Questions and Answers"”、“Drug Shortages”、“Office of Hematology and Oncology Products (OHOP)”、“Pediatric Product Development”,等等。 ☆Drugs@FDA 无论是经常阅览FDA官网,或是...
表2FDA针对某些亚硝胺杂质的AI建议限值 03某些亚硝胺杂质推荐的临时AI限值如果已经上市的药品批次中的亚硝胺杂质含量高于FDA建议的AI限值，并且生产变更或召回可能导致药品供应中断，那么制造商和申请人应立即联系CDER的药品审评工作人员，联系方式drugshortages fda.hhs.gov。FDA会直接与已上市药物的特定制造商或申请...
More information can be found on how FDA addresses drug shortages on our website: https://www.fda.gov/drugs/drug-shortages/frequently-asked-questions-about-drug-shortages#q5
"Demand for the medications Mounjaro, Zepbound, Ozempic, and Wegovy (GLP-1 drugs) has skyrocketed, but supply shortages and high costs have created opportunities for wrongdoers to cash in and endanger consumers," they wrote.美国食品和药物管理局（Food and Drug Administration）周五宣布，已正式宣布...
FDA Forms Drug Shortages Task Force
DrugShortages功能相对简单,只是FDA的一小步,却是移动医疗的一大步。 上周,美国FDA(食品药物监督管理局)发布了自己的首款移动医疗app,DrugShortages,针对医疗领域专业人士发布药物库存实时信息,帮助用户迅速了解当前主要药物的库存状况。 英途君以为,DrugShortages功能相对简单,只是FDA的一小步,却是移动医疗的一大步。官...
Compounding pharmacies use raw drug ingredients to produce customized versions of prescription medications — for instance, when patients have allergies to certain ingredients. The industry has grown into a multibillion-dollar business over the past decade amid increasing drug shortages. ...
如果已经上市的药品批次中的亚硝胺杂质含量高于FDA建议的AI限值,并且生产变更或召回可能导致药品供应中断,那么制造商和申请人应立即联系CDER的药品审评工作人员,联系方式drugshortages@fda.hhs.gov。FDA会直接与已上市药物的特定制造商或申请人合作,并考虑是否适合推荐临时AI限制。
Eli Lilly shares have risen 30% so far this year, and were trading down about 1% at $758.90. Shares of Danish drugmaker Novo Nordisk(NOVOb.CO)have risen 10.6% this year and were trading 3.5% lower on Thursday. Bernstein analyst Courtney Breen said the FDA’s decision suggests tha...