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Medtech Insight

FDA Boosts Development Of OTC COVID-19 Tests With New Template

FDA Boosts Development Of OTC COVID-19 Tests With New Template

A new template from the US FDA explains what information the agency wants to see in regulating COVID-19 tests to be performed outside the laboratory environment.

Topic Coronavirus FDA Diagnostics

Medtech Insight

COVID-19 Antibody Tests Being Abused To Falsely Diagnose Coronavirus Cases, FDA Says

fda-sign

A negative COVID-19 antibody or serology test, even when authorized by FDA, is a poor indicator of whether an individual currently has or is completely immune from contracting coronavirus, the agency said on 4 May, issuing an updated guidance to drive the lesson home.

Topic Coronavirus Policy & Regulation FDA

In Vivo

FDA Emphasizes Clinical Trial Flexibility During Coronavirus Pandemic

FDA Emphasizes Clinical Trial Flexibility During Coronavirus Pandemic

FDA guidance updated in mid-April offered workarounds for trial sponsors attempting to conduct clinical studies in a time of travel limitations, staffing changes and heightened patient safety issues. For trials involving complex products and administration, such as cell and gene therapies, sponsors must determine whether modified protocols can still maintain trial integrity. If not, it may be time to press pause. 

Topic Coronavirus FDA

Pharmaprojects, Biomedtracker

The Race to Find a COVID-19 Treatment - Infographic

The Race to Find a COVID-19 Treatment - Infographic

Access this infographic which focuses on Gilead’s drug Remdesivir which currently shows the greatest promise for the likelihood of approval as a possible treatment to effectively treat the virus. The infographic highlights the drug summary and profile, the number of patients in each trial phase, and the history of events that have moved this product through the development process.

Topic Coronavirus FDA Drug Review

Medtech Insight

Guidance FDA Will Look Other Way If Manufacturers Modify Imaging Systems To Fight COVID19

Guidance FDA Will Look Other Way If Manufacturers Modify Imaging Systems To Fight COVID19

The US agency has relaxed its enforcement policy for X-ray, ultrasound and magnetic resonance imaging systems, as well as software for analyzing images, as US health care workers fight the novel coronavirus.

Topic Coronavirus FDA

Biomedtracker, Datamonitor Healthcare

2020 Early Outlook Webinar

Anticipate the biggest, most impactful expected catalysts of early 2020 with the guidance and insights from Pharma Intelligence. Building off Biomedtracker’s Early 2020 Outlook report, our live webinar will include market context for these upcoming milestones and additional insights from Datamonitor Healthcare’s Therapeutic Area Directors.

Topic FDA

Pink Sheet

For Coronavirus US FDA Is At The Podium But Not On The Task Force

Hahn speaks at Coronavirus briefing

The FDA is curiously not one of the HHS entities coordinating the US response to the outbreak, but must monitor for manufacturing disruptions and shortages, as well as approve new treatments and diagnostics.

Topic FDA Vaccines Infectious Diseases Coronavirus

Medtech Insight

QUOTED. 24 January 2020. Megan McSeveney.

Quoted_24_January_2020

The FDA has readied plans for hastened emergency-use approvals of coronavirus test kits after an infected US citizen returned to Washington State from Wuhan province in China. See what the FDA’s Megan McSeveney said about it here.

Topic Drug approval Coronovirus FDA

HBW Insight

OTC Drug Oversight By US FDA Split Among Two Divisions In Reorganization

OTC_Drug_Oversight_By_US

CDER Office of New Drugs changes its organization including establishing Office of Nonprescription Drugs and splitting the office into Division of Nonprescription Drug Products I and DNDP II. A Division of Regulatory Operations for Nonprescription Drugs will be comprised of regulatory staff from the ONPD divisions and will report to OND’s regulatory office. Non-clinical ONPD staff will report to the office director.

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