December 19, 2016December 21, 2016 Drug & Device Advisory Group Other Clin. Pharm. Card: INTRAROSA INTRAROSA (prasterone) vaginal inserts INDICATION: Steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. Mechanism of Action Prasterone is an inactive endogenous steroid and is converted into active androgens …
February 3, 2017 Drug & Device Advisory Group Link and Learn Best Practices: FDA and IND Sponsor Communications Philosophy on Timely Interactive Communication Scope of Appropriate Interactions Types of Advice Expectations for Response Timing Best Practices and Communication Methods LEARN Share this: Email Print WhatsApp Like this: Like Loading… Published by Drug & Device Advisory …
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Advance Development of Novel Coronavirus Medical Countermeasures (MCM) FDA collaborating with interagency partners, product developers, international partners and global regulators to Expedite development and availability of MCM to diagnose, treat, mitigate, prevent Utilize pathways, including Emergency Use Authorization (EUA) to more rapidly make MCM available Provide regulatory advice, guidance, and technical assistance to sponsors developing …
February 10, 2020 Drug & Device Advisory Group FDA Briefs Market Authorizations: 2019-nCoV diagnostic, ERVEBO Ebola vaccine, TEPEZZA for thyroid eye disease 2019-nCoV Real-Time RT-PCR Diagnostic Panel CDC INTENDED USE: For the presumptive qualitative detection of nucleic acid from the 2019-nCoV in upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, lower …
February 26, 2020 Drug & Device Advisory Group Link and Learn Clinical Trial of Remdesivir to Treat COVID-19 NIH (NIAID) Clinical Trial of Remdesivir to Treat COVID-19 Begins Randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral REMDESIVIR in hospitalized adults diagnosed with COVID-19 Remdesivir is an investigational broad-spectrum antiviral …
June 21, 2018 Drug & Device Advisory Group Link and Learn Mobile App for Drug Shortages FDA Drug Shortages Mobile App CDER Drug Shortages Staff (DSS) works with pharmaceutical manufacturers, review divisions, compliance and other components of FDA to manage product shortages Easy to use App to quickly locate current drug shortages and other important information …
FDA Approvals: EXONDYS 51, AMJEVITA Drug & Device Advisory Group 2 years ago Advertisements FDA BRIEF: Week of September 19, 2016 EXONDYS 51 (eteplirsen) injection Sarepta Therapeutics, Cambridge, MA, USA INDICATION: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 …
Month: May 2021 May 2, 2021 Drug & Device Advisory Group FDA Briefs News and Views: Janssen COVID vaccine pause lifted, Guidance for developing COVID drugs, New pharmacometrics approach, Standards to ban menthol cigarettes, CDRH patient science, Opioid safe disposal, Colorectal cancer screening FDA and CDC Lift Recommended Pause on Janssen Vaccine Use Following Thorough …
September 19, 2016 Drug & Device Advisory Group Link and Learn FDA Division of Biology, Chemistry, and Materials Science WHAT: Part of Office of Science and Engineering Laboratories (OSEL), CDRH WHY: Determine effects of implanted devices, potential device adverse effects, source and impact of device degradation Develop experimental data, test methods, and protocols Develop measurements, …
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June 22, 2015 Drug & Device Advisory Group Other Habitual chocolate consumption could reduce the risk of cardiovascular disease Authors in a study examined the association between chocolate intake and the risk of future cardiovascular events in total of 20951 men and women. Authors evaluated chocolate consumption and cardiovascular outcomes. Results suggested that higher chocolate …
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