fda FDA Guidance on Clinical Trials During COVID-19 Pandemic By eyeonfda.com Published On :: Fri, 20 Mar 2020 12:34:27 +0000 Much attention has been paid to the impact of the COVID-19 pandemic on the supply chain for medicines we rely on, but there has been less focus on the impact of medicines yet to come. The advancements in cancer care … Continue reading → Full Article Clinical Trials FDA Policy #COVID-19 #coronavirus #pharma
fda Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 3 – FDA Adds Resources to Facilitate COVID-19 Research By eyeonfda.com Published On :: Wed, 01 Apr 2020 12:05:05 +0000 With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading → Full Article Current Affairs FDA Policy
fda Impact of COVID-19 on FDA Enforcement and Approvals – Part 5 – FDA Provides Update to Shape Expectations on New Approvals By eyeonfda.com Published On :: Fri, 17 Apr 2020 15:45:55 +0000 In response to written questions submitted last month regarding the potential for delays, FDA had stated that “CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak.” In a subsequent blog … Continue reading → Full Article Approval Announcements COVID19 FDA Policy #coronavirus #COVID19
fda FDA and FTC: Coronavirus Products Are Fraudulent, Could Delay Treatment By cohealthcom.org Published On :: Mon, 16 Mar 2020 19:02:11 +0000 March 16, 2020 – Amid rising concerns over “Novel Coronavirus Disease 2019” (COVID-19), the Food and Drug Administration and the Federal Trade Commission took action last week against seven companies for selling fraudulent COVID-19 products. The regulators sent Warning Letters to the companies because these products “are unapproved drugs that pose significant risks to patient […] Full Article Regulatory/FDA Coronavirus COVID-19 FDA FDA commissioners FDA enforcement FTC Jon Bigelow PURELL unapproved drug Warning Letter
fda Emergency Relief Package Yields Increased FDA Funding, OTC Revisions By cohealthcom.org Published On :: Mon, 30 Mar 2020 16:04:19 +0000 March 30, 2020 – In addition to providing millions of Americans and many industries with financial support during the coronavirus outbreak, the emergency relief bill passed by Congress and signed into law by President Donald Trump on Friday accrues additional funding for the Food and Drug Administration’s coronavirus efforts and makes important changes to how […] Full Article Legislative Congress Coronavirus COVID-19 emergency relief fda funding Jon Bigelow OTC regulation OTC user fees President Trump sunscreen
fda FDA Streamlines COVID-19 Product Pathways, Continues to Crack Down on Misleading Claims By cohealthcom.org Published On :: Mon, 13 Apr 2020 19:38:22 +0000 April 13, 2020 – The Food and Drug Administration (FDA) is responding to the challenges of COVID-19 in new ways that streamline product review and policy approaches, while also ensuring that entities promoting unapproved products that claim to be effective against the virus do not go unchecked. Last week, the FDA and the Federal Trade […] Full Article Regulatory/FDA clinical trials COVID-19 FDA FDA approval process FDA enforcement FTC Jon Bigelow promoting unapproved drug unapproved drug Warning Letter
fda COVID-19 Pandemic Likely to Affect FDA Product Approval Timelines By cohealthcom.org Published On :: Mon, 27 Apr 2020 17:50:36 +0000 April 27, 2020 – As the COVID-19 pandemic continues, the Food and Drug Administration (FDA) must balance safeguarding public health with the desire for timely product reviews. Staff members at the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are working diligently to keep all of these balls in […] Full Article Regulatory/FDA Biohaven Bristol-Myers Squibb clinical trials COVID-19 drug approvals FDA approval process FDA Approvals
fda FDA delays decision on approval of Bristol Myers' CAR-T By www.fiercebiotech.com Published On :: Wed, 06 May 2020 12:02:53 +0000 The FDA has delayed its decision on whether to approve Bristol Myers Squibb’s CAR-T cell therapy by three months. Bristol Myers attributed the delay to its submission of additional information upon the request of the FDA. Full Article
fda FDA’s Final Device Establishment Inspections Guidance Misses the Mark By feedproxy.google.com Published On :: Thu, 23 Apr 2020 09:19:49 +0000 By Rachael E. Hunt — Full Article cGMP Compliance Medical Devices
fda Not So Smooth of a “Transition”: FDA Sued Over Deemed BLA Transitions – or Lack Thereof By feedproxy.google.com Published On :: Tue, 28 Apr 2020 02:14:24 +0000 By Sara W. Koblitz — Full Article Biosimilars Prescription Drugs and Biologics
fda FDA Law Alert – May 2020 By feedproxy.google.com Published On :: Thu, 07 May 2020 04:23:28 +0000 Full Article Cannabis COVID19 Drug Development Medical Devices Prescription Drugs and Biologics
fda Novel targeted drugs approved by the NMPA and FDA in 2019 By feeds.nature.com Published On :: 2020-05-08 Full Article
fda FDA-approved disulfiram inhibits pyroptosis by blocking gasdermin D pore formation By feeds.nature.com Published On :: 2020-05-04 Full Article
fda Why legislative proposals to improve drug and device development must look beyond FDA approvals By webfeeds.brookings.edu Published On :: Tue, 28 Apr 2015 08:00:00 -0400 Legislative proposals to accelerate and improve the development of innovative drugs and medical devices generally focus on reforming the clinical development and regulatory review processes that occur before a product gets to market. Many of these proposals – such as boosting federal funding for basic science, streamlining the clinical trials process, improving incentives for development in areas of unmet medical need, or creating expedited FDA review pathways for promising treatments – are worthy pursuits and justifiably part of ongoing efforts to strengthen biomedical innovation in the United States, such as the 21st Century Cures initiative in the House and a parallel effort taking shape in the Senate. What has largely been missing from these recent policy discussions, however, is an equal and concerted focus on the role that postmarket evidence can play in creating a more robust and efficient innovation process. Data on medical product safety, efficacy, and associated patient outcomes accrued through routine medical practice and through practical research involving a broad range of medical practices could not only bolster our understanding of how well novel treatments are achieving their intended effects, but reinforce many of the premarket reforms currently under consideration. Below and in a new paper, we highlight the importance of postmarket evidence development and present a number of immediately achievable proposals that could help lay the foundation for future cures. Why is postmarket evidence development important? There are a number of reasons why evidence developed after a medical product’s approval should be considered an integral part of legislative efforts to improve biomedical innovation. First and foremost, learning from clinical experiences with medical products in large patient populations can allow providers to better target and treat individuals, matching the right drug or device to the right patient based on real-world evidence. Such knowledge can in turn support changes in care that lead to better outcomes and thus higher value realized by any given medical product. Similarly, data developed on outcomes, disease progression, and associated genetic and other characteristics that suggest differences in disease course or response to treatment can form the foundation of future breakthrough medical products. As we continue to move toward an era of increasingly-targeted treatments, this important of this type of real-world data cannot be discounted. Finally, organized efforts to improve postmarket evidence development can further establish infrastructure and robust data sources for ensuring the safety and effectiveness of FDA-approved products, protecting patient lives. This is especially important as Congress, the Administration, and others continue to seek novel policies for further expediting the pre-market regulatory review process for high-priority treatments. Without a reliable postmarket evidence development infrastructure in place, attempts to further shorten the time it takes to move a product from clinical development to FDA approval may run up against the barrier of limited capabilities to gather the postmarket data needed to refine a product’s safety and effectiveness profile. While this is particularly important for medical devices – the “life cycle” of a medical device often involves many important revisions in the device itself and in how and by whom it is used after approval – it is also important for breakthrough drugs, which may increasingly be approved based on biomarkers that predict clinical response and in particular subpopulations of patients. What can be done now? The last decade has seen progress in the availability of postmarket data and the production of postmarket evidence. Biomedical researchers, product developers, health care plans, and providers are doing more to collect and analyze clinical and outcomes data. Multiple independent efforts – including the U.S. Food and Drug Administration’s Sentinel Initiative for active postmarket drug safety surveillance, the Patient-Centered Outcomes Research Institute’s PCORnet for clinical effectiveness studies, the Medical Device Epidemiology Network (MDEpiNet) for developing better methods and medical device registries for medical device surveillance and a number of dedicated, product-specific outcomes registries – have demonstrated the powerful effects that rigorous, systematic postmarket data collection can have on our understanding of how medical products perform in the real-world and of the course of underlying diseases that they are designed to treat. These and other postmarket data systems now hold the potential to contribute to data analysis and improved population-based evidence development on a wider scale. Federal support for strengthening the processes and tools through which data on important health outcomes can be leveraged to improve evidence on the safety, effectiveness, and value of care; for creating transparent and timely access to such data; and for building on current evidence development activities will help to make the use of postmarket data more robust, routine, and reliable. Toward that end, we put forward a number of targeted proposals that current legislative efforts should consider as the 2015 policy agenda continues to take shape: Evaluate the potential use of postmarket evidence in regulatory decision-making. The initial Cures discussion draft mandated FDA to establish a process by which pharmaceutical manufacturers could submit real-world evidence to support Agency regulatory decisions. While this is an important part of further establishing methods and mechanisms for harnessing data developed in the postmarket space, the proposed timelines (roughly 12 months to first Guidance for Industry) and wide scope of the program do not allow for a thoughtfully-, collaboratively-considered approach to utilizing real-world evidence. Future proposals should allow FDA to take a longer, multi-stakeholder approach to identify the current sources of real-world data, gaps in such collection activities, standards and methodologies for collection, and priority areas where more work is needed to understand how real-world data could be used. Expand the Sentinel System’s data collection activities to include data on effectiveness. Established by Congress in 2007, Sentinel is a robust surveillance system geared toward monitoring the safety of drugs and biologics. In parallel to the program for evaluating the use of RWE outlined above, FDA could work with stakeholders to identify and pursue targeted extensions of the Sentinel system that begin to pilot collection of such data. Demonstration projects could enable faster and more effective RWE development to characterize treatment utilization patterns, further refine a product’s efficacy profile, or address pressing public health concerns – all by testing strategic linkages to data elements outside of Sentinel’s safety focus. Establish an active postmarket safety surveillance system for medical devices. Congress has already acted once to establish device surveillance, mandating in 2012 that Sentinel be expanded to include safety data on medical devices. To date, however, there has been no additional support for such surveillance or even the capability of individually tracking medical devices in-use. With the recently finalized Unique Device Identifier rule going effect and the ability to perform such tracking on the horizon, the time is now to adopt recent proposals from FDA’s National Medical Device Postmarket Surveillance System Planning Board. With Congressional authorization for FDA to establish an implementation plan and adequate appropriations, the true foundation for such a system could finally be put into place. These next steps are practical, immediately achievable, and key to fully realizing the intended effect of other policy efforts aimed at both improving the biomedical innovation process and strengthening the move to value-based health care. Authors Mark B. McClellanGregory W. DanielMorgan Romine Full Article
fda GMO salmon gets final FDA approval By www.treehugger.com Published On :: Thu, 19 Nov 2015 11:49:50 -0500 The U.S. Food and Drug Administration has approved the first genetically engineered animal for human consumption. Full Article Business
fda FDA Punts On Banning Bisphenol A; NRDC is Outraged, But I Think They Got It Right By www.treehugger.com Published On :: Tue, 03 Apr 2012 06:51:00 -0400 It is one thing to ban something, it is another thing to have something to replace it with at hand. We don't. Full Article Business
fda BPA is FDA's Latest Gift to Food Industry By www.treehugger.com Published On :: Thu, 05 Apr 2012 12:15:00 -0400 Without a hint of irony, FDA maintains several web pages with helpful information for parents and others wishing to avoid BPA, such as: “What You Can Do to Minimize Your Infant’s Exposure to BPA.” Full Article Living
fda Bisphenol A Now Illegal In American Baby Bottles and Sippy Cups, No Thanks to FDA By www.treehugger.com Published On :: Wed, 18 Jul 2012 08:33:00 -0400 It seems that the only people who benefit from this rule change are the members of the American Chemistry Council who make BPA. Full Article Living
fda Novartis announces FDA approval for Jadenu™ to simplify treatment administration for patients with chronic iron overload - Dr. Elliott Vichinsky on Jadenu By feedproxy.google.com Published On :: 31 Mar 2015 13:15:00 EDT Elliott Vichinsky, MD, University of California, San Francisco (UCSF) Benioff Children's Hospital Oakland Full Article Healthcare Hospitals Medical Pharmaceuticals Pharmaceuticals New Products Services Broadcast Feed Announcements FDA Approval MultiVu Video
fda PeriCoach®, New FDA-Approved Pelvic Floor Training System For Women, Now Available - Christine Lewicky-Gaupp, MD By feedproxy.google.com Published On :: 23 Jun 2015 18:30:00 EDT Dr. Lewicky-Gaupp knows what a significant problem UI can be for millions of women – many of whom suffer in silence. Here she explains why the PeriCoach System is an important new treatment option. Full Article Healthcare Hospitals Medical Pharmaceuticals New Products Services Women-related News Broadcast Feed Announcements MultiVu Video
fda Boston Scientific Receives FDA Approval For SYNERGY Bioabsorbable Polymer Drug-Eluting Stent System - A Technology Development Story: meet the SYNERGY™ Stent System engineers By feedproxy.google.com Published On :: 05 Oct 2015 11:10:00 EDT A Technology Development Story: meet the SYNERGY™ Stent System engineers Full Article Healthcare Hospitals Medical Pharmaceuticals Pharmaceuticals Broadcast Feed Announcements FDA Approval MultiVu Video
fda FDA gives emergency authorization for new antigen test to help detect coronavirus quicker and cheaper By www.cnbc.com Published On :: Sat, 09 May 2020 15:00:39 GMT There is a higher chance of false negatives with an antigen test and a negative result may need to be confirmed with an additional PCR test prior to further treatments. Full Article
fda FDA authorizes VitalPatch for monitoring Covid-19 patients—Here's how it works By www.cnbc.com Published On :: Fri, 08 May 2020 18:00:03 GMT CNBC's Tyler Mathisen is joined by Vital Connect CEO Peter Van Haur to talk about how the company's VitalPatch product just got FDA approval to monitor coronavirus patients. Full Article
fda US FDA approves emergency use of Remdesivir for COVID-19 patients By www.mid-day.com Published On :: 3 May 2020 02:03:38 GMT The US food and drug regulatory body has allowed the emergency use of an investigational anti-viral vaccine to treat COVID-19 patients after some researches, including one led by an Indian-American physician, found that the drug helped recover some of the infected cases faster. The Food and Drug Administration (FDA) gave emergency use authorisation (EUA) for the use of investigational anti-viral Remdesivir for the treatment of COVID-19 patients. "I'm pleased to announce that Gilead now has an EUA from the FDA for Remdesivir," US President Donald Trump told reporters at the White House on Friday. Remdesivir is given to patients through a vein one time each day for up to 10 days depending on recommendations of healthcare providers. The US National Institute of Allergy and Infectious Diseases (NIAID) announced the results of a trial involving more than 1,000 people on Wednesday. It found that hospitalised COVID-19 patients with respiratory distress got better quicker than those on a placebo. Specifically, patients on the drug had a 31 percent faster time to recovery. "Although the results were clearly positive from a statistically significant standpoint, they were modest," Anthony Fauci, the scientist who leads the NIAID, said. While not considered a miracle cure, Remdesivir's trial achieved a "proof of concept," according to Fauci that could pave the way for better treatments. Possible side effects of Remdesivir include infusion-related reactions and increases in levels of liver enzymes. "These are not all the possible side effects of Remdesivir. It is still being studied so it is possible that all of the risks are not known at this time," said the FDA. Catch up on all the latest Crime, National, International and Hatke news here. Also download the new mid-day Android and iOS apps to get latest updates. Mid-Day is now on Telegram. Click here to join our channel (@middayinfomedialtd) and stay updated with the latest news This story has been sourced from a third party syndicated feed, agencies. Mid-day accepts no responsibility or liability for its dependability, trustworthiness, reliability and data of the text. Mid-day management/mid-day.com reserves the sole right to alter, delete or remove (without notice) the content in its absolute discretion for any reason whatsoever Full Article
fda Biocon share price rises 3% on receiving EIR from USFDA By www.businesstoday.in Published On :: Fri, 08 May 2020 12:33:06 GMT Share price of Biocon rose up to 3.22% to Rs 360.9 against previous close of Rs 349.65 on BSE Full Article
fda Dr Reddy's Srikakulam plant receives USFDA nod; lifts overhang By www.businesstoday.in Published On :: Fri, 08 May 2020 11:10:35 GMT The move lifts the overhang of a warning letter for a plant that Dr Reddy's had been dealing with for long. Now all their plants have become USFDA compliant Full Article
fda FDA Approved First Dengue Vaccine With Some Restrictions By www.medindia.net Published On :: Dengvaxia, the first vaccine for dengue was approved in 19 countries and European Union by the US Food and Drug Administration (FDA) to prevent dengue Full Article
fda FDA-approved Drugs Help Fight Coronavirus By www.medindia.net Published On :: Drugs approved by U.S. Food and Drug Administration (FDA) may hold promise in fighting the new infection known as coronavirus disease 2019 (COVID-19), stated UTSW scientists. Full Article
fda Teprotumumab, First FDA-approved Drug for Thyroid Eye Disease Proves Effective By www.medindia.net Published On :: Regardless of patient gender, age or smoking status, teprotumumab, the first FDA-approved drug for thyroid eye disease, provides significant improvement Full Article
fda FDA Authorizes First At-Home Saliva Test for COVID-19 By feedproxy.google.com Published On :: U.S. Food and Drug Administration (FDA) approved the first diagnostic test with the option of using home-collected saliva samples for novel coronavirus (COVID-19) testing. Full Article
fda Decades-old Ban on Gay Men Donating Blood Finally Removed by the FDA By feedproxy.google.com Published On :: In a major policy decision the Food and Drug Administration (FDA) of the USA has lifted the ban on gay and bisexual men Full Article
fda FDA flags risks for virus drug promoted by Trump By www.ft.com Published On :: Fri, 24 Apr 2020 18:57:45 GMT US regulator cautions against using chloroquine outside of hospitals or clinical trials Full Article
fda FDA gives emergency authorisation to remdesivir By www.ft.com Published On :: Fri, 01 May 2020 20:52:03 GMT US-led trial shows positive results in hastening recovery time for coronavirus patients Full Article
fda FDA authorizes production of a new ventilator that costs up to 25x less than existing devices By techcrunch.com Published On :: Wed, 15 Apr 2020 18:26:43 +0000 The U.S. Food and Drug Administration (FDA) has authorized the manufacture of the Coventor ventilator, a new hardware design first developed by the University of Minnesota. The project sought to create a ventilator that could provide the same level of life-saving care as existing ventilator models, but with a much lower cost to help ramp […] Full Article Biotech Gadgets Hardware Health Science TC coronavirus COVID-19 Food and Drug Administration medical device medicine medtronic Minnesota Tesla United States University of Minnesota
fda The 5:30 A.M. Warrior Call: The FDA Approves Phase 2 Testing of Coronavirus Vaccine (5/8/2020) By feedproxy.google.com Published On :: Fri, 08 May 2020 19:58:00 GMT Biotech company Moderna said it plans to start phase 2 trials with 600 participants shortly. Full Article Coronavirus
fda La La Anthony dazzles in orange satin as she joins star-studded guest list at CFDA Awards in NYC By www.dailymail.co.uk Published On :: Tue, 05 Nov 2019 15:12:22 GMT Anthony served body last week in a sexy Maleficent costume at her annual Halloween party. She wore the classic horns and wings with a black lace catsuit, revealing her sexy lingerie underneath. Full Article
fda Zika virus test called for all blood donations by FDA By www.dailymail.co.uk Published On :: Sat, 27 Aug 2016 03:00:36 GMT The move, ordered by the Food and Drug Administration on Friday, is a major expansion in a bid intended to protect the nation's blood supply from the mosquito-borne virus. Full Article
fda FDA says Pepcid and Prilosec do NOT contain carcinogen in Zantac By www.dailymail.co.uk Published On :: Thu, 24 Oct 2019 21:31:51 GMT The Food and Drug Administration on Wednesday told Americans that Prilosec, Pepcid and other alternatives are free of NDMA found in Zantac - but they have other risks. Full Article
fda Gigi Hadid goes green while Bella Hadid sports faux piercings at 2019 CFDA/Vogue Fashion Fund Awards By www.dailymail.co.uk Published On :: Tue, 05 Nov 2019 09:34:44 GMT Gigi and Bella Hadid led the fashion stars at the 2019 CFDA/Vogue Fashion Fund Awards. Gigi was clad in a sheer olive dress while Bella wore a black velvet suits with faux piercings. Full Article
fda Ex-FDA commissioner Scott Gottlieb predicts above 100,000 will die from coronavirus by end of June By www.dailymail.co.uk Published On :: Sun, 03 May 2020 23:20:07 GMT Dr Scott Gottlieb on Sunday expressed concern that confirmed coronavirus infections and hospitalizations are still increasing in 20 states including Texas and Illinois. Full Article
fda FDA expert warns the US could run out of researchers to run coronavirus drug trials By www.dailymail.co.uk Published On :: Sat, 25 Apr 2020 01:11:52 GMT Head of the FDA drug research arm, Dr Janet Woodcock, warned in a webinar that if every potential coronavirus drug is trialled separately, we could run out of scientists to run them the studies. Full Article
fda FDA gives emergency approval to Roche's coronavirus antibody blood test By www.dailymail.co.uk Published On :: Mon, 04 May 2020 21:33:48 GMT Swiss drug maker Roche says its coronavirus antibody blood test has a specificity rate of 99.8% and a sensitivity of 100%, meaning it would show very few false positives and no false negatives Full Article
fda FDA warns Purell to STOP claiming its hand sanitizer can kill flu and Ebola By www.dailymail.co.uk Published On :: Tue, 28 Jan 2020 21:02:28 GMT Food and Drug Administration officials hit out at Purell's maker GOJO with a warning letter earlier this month, demanding that the company take down false claims it prevents flu. Full Article
fda FDA warns AGAINST using hydroxychloroquine for coronavirus patients outside of hospitals By www.dailymail.co.uk Published On :: Fri, 24 Apr 2020 22:57:34 GMT The FDA made its warning against using hydroxychloroquine after several reports of abnormal heart rhythms and rapid heart rates in patients who took the medication. Full Article
fda FDA may approve emergency use authorization of Ebola drug remdesivir TODAY By www.dailymail.co.uk Published On :: Wed, 29 Apr 2020 23:19:55 GMT The FDA may announce its decision allowing emergency use authorization of an antiviral remdesivir for coronavirus patients as early as Wednesday. Full Article
fda FDA has APPROVED experimental drug Remdesivir for emergency use for coronavirus patients By www.dailymail.co.uk Published On :: Sat, 02 May 2020 16:11:18 GMT President Donald Trump announced Friday that the FDA has approved the drug remdesivir for emergency use in hospitalized coronavirus patients. Full Article
fda FDA adds 1,500 hand sanitizer manufacturers to meet demand amid the pandemic By www.dailymail.co.uk Published On :: Tue, 28 Apr 2020 03:37:25 GMT In a statement on Monday, the FDA asked that manufacturers add denatured alcohol to hand sanitizers, which renders a bitter taste and makes the liquid less appealing, especially to children. Full Article
fda Ex-FDA commissioner says Americans cannot rely on Europe and China for jab to prevent coronavirus By www.dailymail.co.uk Published On :: Wed, 29 Apr 2020 22:27:47 GMT Dr Scott Gottlieb, who led the FDA between 2017 and April 2019, says its vital the US manufactures the first coronavirus vaccine because it will then be the first nation to recover. Full Article
fda Dr Reddys receives EIR from USFDA for API facility at Srikakulam By www.business-standard.com Published On :: Fri, 08 May 2020 09:16:00 +0530 It may be noted that the site was issued warning letter in November, 2015 after the inspection in 2014, and was under "Official Action Indicated" classification till now. Full Article
fda Biocon receives EIR from USFDA for its small molecules API facility in Bengaluru By www.business-standard.com Published On :: Fri, 08 May 2020 09:21:00 +0530 Powered by Capital Market - Live News Full Article
