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Do the Waive - FDA Implements Informed Consent Waivers for Minimal Risk Studies

USA - August 10 2017 On July 25, 2017, FDA issued a guidance document describing under what circumstances IRBs may now approve consent procedures that waive or alter some...

Heidi Gertner, Robert Church, William F. Ferreira.


To certify or not to certify? FDA has answered the question

USA - June 13 2017 On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device...

Heidi Gertner, Robert Church, Gerard J. Prud'homme, Mike Druckman, Susan S. Lee.


Just One More Day: Compliance Deadline for New ClinicalTrials.gov Regulations is Tuesday, 18 April 2017

USA - April 17 2017 On 21 September 2016, the Department of Health and Human Services (HHS) published a final rule that clarified and expanded the requirements for...

Bert Lao, Robert Church.


Ready, Set Cures Act Expanded Access Policy Deadline is Almost a Go

USA - February 8 2017 As we have mentioned in a previous article, the 21st Century Cures Act (enacted December 13, 2016) gave companies 60 calendar days to make their...

Robert Church.


A “cure” for combination products: 21st Century Cures Act mandates greater transparency of combination product designations

USA - January 25 2017 The 21st Century Cures Act, signed into law on December 13, 2016, ushers in significant, and interesting, changes to the regulatory review of...

Jodi Scott, Heidi Gertner, Robert Church, David M. Fox, Yarmela Pavlovic, Randy Prebula.