COVID-19: FDA’s Stenzel Talks Abbott Test, Future Clearances In Call
People who test negative for COVID-19 using Abbott’s ID Now point-of-care test may need to confirm the result with a second test, a US Food and Drug Administration official said ..... see more
Source : Medtech Insight
FDA Yanks Potentially Faulty COVID-19 Antibody Tests – And More May Be On The Chopping Block
The US Food and Drug Administration has yanked more than two dozen COVID-19 antibody tests after criticism they were too inaccurate to be used. The change comes after the agency ..... see more
Source : Medtech Insight
Device Week, 22 May 2020 – Inside FDA's Plan To Restart On-Site Inspections
Listen to the podcast via the player below: ..... see more
Source : Medtech Insight
What The Pandemic Can Teach Us About Running Clinical Trials
Experience during the COVID-19 pandemic should help to guide companies and regulators towards new ways of approaching clinical trials, with more use of novel study design, remote site monitoring, and ..... see more
Source : 'The Pink Sheet'
Strides Optimistic On Prospects Of Antiviral Portfolio For COVID-19
Adopting a strategy that lives up to the tagline ‘Reset, Resurgent’ that its investor presentations begins with, Strides Pharma Science Ltd. plans to repurpose some existing medicines for ..... see more
Source : 'Scrip Intelligence'
US FDA Generic Approvals Peak In April, But Annual Pace Trends Down
Generic drug approval totals peaked in April as the US Food and Drug Administration’s Office of Generic Drugs continued its teleworking output surge.Full and tentative approval totals reached their highest ..... see more
Source : 'The Pink Sheet'
Real-World Data Partnership On COVID-19: US FDA Drawn To Consistency, Diversity of Aetion's Datasets
The US Food and Drug Administration announced a new COVID-19 real-world data partnership with Aetion this week, a collaboration that was attractive to the regulatory agency because of Aetion’s ability ..... see more
Source : 'The Pink Sheet'
US FDA Pushing Coronavirus Trial Sponsors To Include Control Groups
Amid the rush of coronavirus therapeutic proposals and a drive to gather data quickly, US Food and Drug Administration officials said they continue to push for development program characteristics to ..... see more
Source : 'The Pink Sheet'
When A Sponsor Wants To Proceed On A COVID Product, US FDA Almost Never Says No
US Food and Drug Administration officials do not appear overly interested in tamping down the unprecedented interest in finding a treatment for the coronavirus, despite the enormous workload it is ..... see more
Source : 'The Pink Sheet'
US False COVID-19 Claims Continue Climbing Along With Rate Of Virus’ Spread Globally
Fraudulent claims made in the US for COVID-19 treatments are growing at a rate similar to the spread of the disease itself, the Federal Trade Commission’s latest round of warning letters ..... see more
Source : 'HBW Insight'
UK’s COVID-19 Track-And-Trace Confusion Persists
While the pilot program for the app that is seen as a major element in the UK’s COVID-19 surveillance effort proceeds to its planned conclusion, confusion reigns over the bigger ..... see more
Source : Medtech Insight
Germany Sets COVID-19 Testing Record And Prepares For Future Outbreaks
German COVID-19 testing activity was up again last week, reaching a record 364,716 tests undertaken, 11% more than in the week before. 128 German labs are now contributing data about ..... see more
Source : Medtech Insight
Novartis Oncology Head Discusses Cancer Care Challenge With COVID-19
Susanne Schaffert, president of oncology at Novartis AG, has been reflecting on the catastrophic gaps in cancer care that are resulting from the coronavirus pandemic and the challenges ..... see more
Source : 'Scrip Intelligence'
WHO ‘Showed Leadership’ In Dealing With COVID-19, Says Interim Inquiry
An independent interim review of the World Health Organization’s handling of the coronavirus pandemic has concluded that the organization “demonstrated leadership” and made important progress in its COVID-19 response “considering ..... see more
Source : 'The Pink Sheet'
Beximco Launches First Remdesivir Generic
Bangladesh's Beximco Pharma has claimed a world first after launching a generic version of remdesivir for the treatment of COVID-19. The launch in the firm’s domestic market comes after the ..... see more
Source : 'Generics Bulletin'
