Results 1 to 5 of 59

New FDA Guidance Embraces "Remote Interactive Evaluations" but Stops Short of Permitting Virtual 704(a) Inspections

USA - April 19 2021 As the guidance makes clear, what FDA calls a “remote interactive evaluation” is “not the same as an inspection” under Section 704(a) of the Federal…

Frederick R. Ball, Patrick C. Gallagher, Ph.D.

Florida Adopts New COVID-19 Civil Liability Limitations

USA - April 5 2021 The new statutes also create qualified immunity for individuals, businesses and organizations facing COVID-19-related claims and…

Harvey W. Gurland, Jr.

Florida Legislators Introduce Bills That Would Impose Strict Prerequisites to Bringing COVID-19 Personal Injury Claims

USA - January 11 2021 If enacted, the legislation would impose a one-yearstatute of limitations, meaning that any action for a COVID-19-related claim…

Harvey W. Gurland, Jr.

Florida Industry Group Urges State to Limit Legal Liability for Florida Businesses

USA - December 4 2020 The RESET Task Force’s proposals come as other states consider similar types of recommended actions, including establishing…

Harvey W. Gurland, Jr.

FDA Clarifies Types of Evidence It Will Consider When Determining a Medical Product's "Intended Use"

USA - October 6 2020 The proposed rule identifies types of evidence (along with examples of such evidence) that would not be determinative of intended…

Frederick R. Ball