Newsletter - September 7, 2023
FDA’s Latest Advice for Strategic Considerations for 510K Applications
510k constitutes both the most common kind of device market approval applications and the most controversial ones due to predicate creep, need or not of clinical trials, and the amount of supporting information needed for clearance by the FDA. These very critical strategic considerations could vastly affect the...Read More
FDA Funding for Orphan Drug Clinical Trials
The US FDA offers a grant of up to $3.6 million in non-dilutive funding to researchers developing new treatments for orphan drugs with an unmet medical need through a competitive selection process. Although the orphan drug development grant is not discussed much in funding circles, it offers several benefits, additional...Read More
FDA’s Latest Advice for Strategic Considerations for 510K Applications
510k constitutes both the most common kind of device market approval applications and the most controversial ones due to predicate creep, need or not of clinical trials, and the amount of supporting information needed for clearance by the FDA. These very critical strategic considerations could vastly affect the...Read More
FDA Funding for Orphan Drug Clinical Trials
The US FDA offers a grant of up to $3.6 million in non-dilutive funding to researchers developing new treatments for orphan drugs with an unmet medical need through a competitive selection process. Although the orphan drug development grant is not discussed much in funding circles, it offers several benefits, additional...Read More
