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TXT Panel Mixed Vote on Merck’s Covid Drug [1238 Words] [ Price : $8.95]
FDA’s Antimicrobial Drugs Advisory Committee narrowly votes 13-10 to recommend an emergency use authorization for Merck’s oral antiviral molnupiravir for treating Covid-19 patients.
11/30/2021
 
 
TXT Teleflex Recalls Percutaneous Thrombolytic Device [212 Words] [ Price : $8.95]
Teleflex recalls its Arrow-Trerotola Over-The-Wire Percutaneous Thrombolytic Device Kit, 7FR, after receiving reports about the inner lumen becoming detached.
11/30/2021
 
 
TXT AstraZeneca, Merck sNDA for Lynparza [196 Words] [ Price : $8.95]
FDA accepts for priority review an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) for the adjuvant treatment of patients with BRCA-mutated, human epidermal growth factor receptor 2-negative high-risk early breast cancer.
11/30/2021
 
 
TXT Attorneys See Questions in LDT Policy Change [2688 Words] [ Price : $8.95]
Three Hyman, Phelps attorneys say an HHS announcement withdrawing a Trump administration policy on FDA review of laboratory-developed tests leaves many questions unanswered.
11/30/2021
 
 
TXT Fennec Pharma Hit with 2nd Complete Response [266 Words] [ Price : $8.95]
FDA sends Fennec Pharmaceuticals a second complete response letter on its NDA for Pedmark (sodium thiosulfate, intravenous) for preventing ototoxicity (hearing loss) associated with cisplatin chemotherapy in pediatric patients with localized, non-metastatic, solid tumors.
11/30/2021
 
 
TXT Nominations for Radiation Safety Standards Panel [70 Words] [ Price : $8.95]
Federal Register notice: FDA requests nominations for voting members to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee.
11/30/2021
 
 
TXT Real-World Data Guidance on Using Registries [84 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance on Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products.
11/30/2021
 
 
TXT Comments on FDA Real-World Data Guidance [2897 Words] [ Price : $8.95]
Drug companies and other stakeholders respond to an FDA draft guidance on using electronic health records and claims data in real-world data studies.
11/30/2021
 
 
TXT Regulatory Review Period for Zepzelca [100 Words] [ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Pharma Mar’s Zepzelca (lurbinectedin).
11/29/2021
 
 
TXT Info Collection on Rx Drug User Fee Program [100 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection revision entitled “Prescription Drug User Fee Program.”
11/29/2021
 
 
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