US FDA Recommendations On Developing Serial COVID-19 Tests Could Accelerate OTC Approval
Source : 'HBW Insight'
The US Food and Drug Administration has made available a development template with recommendations to streamline emergency use authorizations of screening tests for serial COVID-19 testing, which developers can consider...
Gottlieb: No ‘Plan B’ If Woodcock Isn’t Nominated As US FDA Commissioner
Source : 'HBW Insight'
Former commissioner Scott Gottlieb doesn’t see a “plan B” for US Food and Drug Administration leadership beyond Janet Woodcock being moved from acting to permanent commissioner.
Gottlieb also expects that enforcing...
US FDA’s Abernethy Leaves Behind Legacy Of Tech Modernization, Real-World Data
Source : 'HBW Insight'
Amy Abernethy’s decision to leave the US Food and Drug Administration after just more than two years boiled down to two reasons: wanting to see initiatives she helped establish move...
FTC Familiar With Direct Seller’s COVID-19 Claims Questioned By US Industry Self-Regulation Group
Source : 'HBW Insight'
A California health and nutrition product direct seller’s COVID-19-related ad claims that an industry self-regulation group suggests the Federal Trade Commission scrutinize previously had appeared on the agency’s radar.
The BBB...
US OTC Monograph Facilty Fees Increase With Pandemic-Inspired Sanitizer Makers Exempted
Source : 'HBW Insight'
Businesses that began making hand sanitizers in response to the COVID-19 pandemic won’t pay US OTC drug monograph program facility fees but firms subject to the requirement will pay $6,000...