Regulatory and Compliance Databases
PharmTech compiled a list of useful regulatory and compliance databases found on the web.
Searchable Databases
US FDA
Adverse Event Reporting System (AERS)
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
Bioresearch Monitoring Information System (BMIS)
Clinical Investigator Inspection List (CLIIL)
Current Good Manufacturing Practice (CGMP) Regulations
Dissolution Methods for Drug Products
Drug Firm Annual Registration Status
Inactive Ingredient Search for Approved Drug Products
Postmarket Requirements and Commitments
EDQM
Supplier andMaterial Certification Database
EU
ICH
ICH's Library ofPresentations and Training Materials, Concept Papers & Business Plans, Guidelines, Questions& Answers, and more.
PQRI
Risk-managing training tools from the Product Quality Research Institute
USP
USP's Medicines Quality Database
SFDA
State Food and Drug Administration, P.R. China
PacBio Chosen as Tech Partner for Global Alzheimer’s Disease Research Project
April 23rd 2025The project, the North African Dementia Registry, will unite multiple entities for the purpose of developing a comprehensive dataset to advance the research community’s understanding of Alzheimer’s disease and other dementias in diverse populations.
Transformations in Drug Development for Cell and Gene Therapies
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
