Brenda Sandburg

Latest From Brenda Sandburg
GDUFA Collections Fell Short In FY 2021
The US FDA reports that GDUFA met all of its 11 performance enhancement goals in FY 2021, while BsUFA is on track to meet 16 of 27 of its performance enhancement goals.
US Supreme Court’s EPA Ruling Expected To Have Limited Impact On FDA Regulations
Court restricts EPA’s ability to regulate greenhouse gas emissions saying agency must have “clear congressional authorization” to address “major questions.” Decision is not likely to pose a problem for the FDA unless it were to regulate something new, attorneys say.
Patient-Focused Drug Development Guidance: Determining When A Clinical Outcome Assessment Is Appropriate
A US FDA draft guidance on selecting and developing fit-for-purpose clinical outcome assessments specifies the evidence that can be provided to support using a COA in a particular context.
Operation Warp Speed For Rare Diseases? US FDA Is Considering Pilot Programs
CBER director Peter Marks says the FDA may evaluate giving gene therapy products the ‘degree of responsiveness’ that COVID-19 vaccines received. In a discussion of the pandemic's effects on staff retention, CDER director Patrizia Cavazzoni says attrition rates are back to historical levels.
US FDA May Play Central Role In Assuring Access To Mifepristone Post Roe v. Wade
HHS will take steps to increase access to abortion medication and prevent states from banning it, Secretary Becerra says, but also is questioned about whether the FDA can speed up certification of pharmacies and if the Justice Department would sue states banning access.
PDUFA Collections Exceeded Target In FY 2021, While GDUFA Fell Short
The US FDA reports that the prescription drug user fee program met 27 of its 29 commitments by the end of FY 2021 and the biosimilar user fee program is on track to meet 16 of 27 of its performance enhancement goals.