FDA Issues Guidance on Bioresearch Monitoring Content for NDAs and BLAs
The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.
FDA published draft guidance on Feb. 21, 2018 detailing the electronic submission of data and information from studies used to support the safety and efficacy claims in new drug applications (NDAs) and biologics license applications (BLAs), as well as supplemental applications containing new clinical study reports and certain investigational new drug applications. The agency’s Center for Drug Evaluation and Research (CDER) uses such data to identify sites for FDA inspections plan for bioresearch monitoring. FDA states in the guidance that these types of data must be submitted electronically in the specified format, effective 24 months after the final guidance is issued.
The draft guidance addresses the submission of clinical study-level information, subject-level data line listings, and summary-level clinical site dataset. The information must be submitted with NDAs, BLAs, and supplement applications electronically using FDA’s Electronic Submission Gateway or by using appropriate physical media. The new draft guidance supersedes previously issued draft guidance.
Source: FDA
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space
May 7th 2025The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.
