Author name: druganddevicedigest

FDA BRIEF: Week of June 27, 2016 EPCLUSA (sofosbuvir and velpatasvir) tablet Gilead Sciences, Inc., CA, USA INDICATION: Treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection : (i) without cirrhosis or with compensated cirrhosis  (ii) with decompensated cirrhosis for use in combination with ribavirin UNMET …

FDA Approvals: EPCLUSA, RAINDROP INLAY, XPERT CARBA-R ASSAY – Drug and Device Digest Read More »

EVENITY (romosozumab-aqqg) injection, for subcutaneous use  Amgen INDICATION FOR USE: Treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy Limitations of Use : Anabolic effect wanes after 12 monthly …

Drug and Vaccine Authorizations: EVENITY for osteoporosis, DENGVAXIA for Dengue, MAVYRET for Hep C in children, BENLYSTA in SLE, TIBSOVO for AML, VYNDAQEL/VYNDAMAX for cardiomyopathy, RUZURGI for LEMS – Drug and Device Digest Read More »

Week of Nov 27, 2017 CDER Conversation: The FDA’s Sentinel Initiative The Sentinel Initiative is national electronic system that monitors safety of marketed drugs, vaccines, biologics and medical devices Includes Active Risk Identification and Analysis (ARIA) system 17 data partners such as insurance companies, HMOs, and hospitals Access to 223 million members Data derived from administrative claims …

FDA News and Views: Sentinel Initiative, Innovation and International Regulation, PEPFAR, 3D Printing – Drug and Device Digest Read More »

December 21, 2016 Drug & Device Advisory Group Other Clin. Pharm. Card: SOLIQUA SOLIQUA 100/33 (insulin glargine and lixisenatide injection), for subcutaneous use  Sanofi-Aventis U.S. Bridgewater, NJ, USA INDICATION:  Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 60 units daily) or …

Other – Drug and Device Digest Read More »

FDA BRIEF: Week of April 25, 2016 Best practices on how to improve the drug product and container closure design Examples that have resulted in postmarketing medication errors Minimize errors by proactive risk assessments and addressing risks before marketing CONSIDERATIONS AT EARLY STAGE OF DRUG PRODUCT DESIGN TO MINIMIZE MEDICATION ERRORS :  End Users and Environments …

FDA Guidances: Medication Errors, Digital Pathology, Data Integrity & CGMP – Drug and Device Digest Read More »

June 29, 2015June 29, 2015 Drug & Device Advisory Group Other Google developing a nanoparticle pill for detection of cancer and other diseases The pill will identify cancers and other diseases before they become a problem. The pill contains magnetized nanoparticles attached with antibodies or other proteins are specific for the disease biomarker such as …

June 2015 – Drug and Device Digest Read More »

FDA BRIEF: Week of July 29, 2016 SCOPE: Real-World Data (RWD): Data collected from sources outside of traditional clinical trials Real-World Evidence (RWE): Evidence derived from aggregation and analysis of RWD elements. FDA’s National Evaluation System leverages RWD to identify safety problems, to better understand the benefit-risk profile, reduce the time and cost of evidence …

FDA Device Guidances: Real-World Evidence, UDI, Adaptive Design, General Wellness – Drug and Device Digest Read More »