Pharmaceutical Technology on MSN

FDA’s commissioner vouchers prompt questions about award process

Despite the FDA’s CNPV scheme generating high interest, the process around how voucher awards are prioritised remains unclear ...
BioSpace

FDA Policy Tracker 2026: Priority Vouchers Questioned, PRVs Return

A year of significant policy change at the FDA brought momentum and scrutiny into the new year. As 2026 gets underway, biopharma companies are responding to sweeping vaccine changes while concerns ...
BioSpace

FDA Launches PreCheck Program, Intended To Bring Manufacturers Home

The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the ...
Fierce Pharma

FDA emphasizes drug ingredients, production pledges as it debuts PreCheck manufacturing program

The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit requests to take part in the program. Companies are limited to one submission ...
STAT

FDA Commissioner Marty Makary tries to soothe staff concerns over voucher program

At an employee town hall, FDA leaders tried to quell staff concerns about a controversial new program to fast-track certain ...
Convenience Store News

FDA Streamlines PMTA Process With Improved Web-Based Options

CTP Portal Next Generation also accepts Substantial Equivalence submissions. Step-by-step instructions on completing the forms; A more user-friendly interface that helps guide applicants through the ...
JD Supra

Court gives new life to the post-CRL administrative hearing process, rules that FDA can deny hearing only when evidence is ‘conclusively deficient’

On August 15, 2025, the U.S. Court of Appeals for the D.C. Circuit limited FDA's ability to deny a hearing on the approvability of a new drug application (NDA) based on a lack of “substantial evidence ...