Regulatory News Archives

5 02, 2021

FDA provides new guidance to industry on manufacture of cell and gene therapy products during COVID-19 pandemic
Gallery

FDA provides new guidance to industry on manufacture of cell and gene therapy products during COVID-19 pandemic

webmaster2026-04-22T18:04:47+00:00

The Center for Biologics Evaluation and Research (CBER) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. CBER uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight. Cellular therapy products include cellular immunotherapies, cancer vaccines, [...]

FDA provides new guidance to industry on manufacture of cell and gene therapy products during COVID-19 pandemicwebmaster2026-04-22T18:04:47+00:00

12 08, 2020

FDA approves first liquid biopsy next-generation sequencing companion diagnostic test
Gallery

FDA approves first liquid biopsy next-generation sequencing companion diagnostic test

webmaster2026-04-22T18:03:33+00:00

Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell lung cancer (NSCLC). This is the first approval to [...]

FDA approves first liquid biopsy next-generation sequencing companion diagnostic testwebmaster2026-04-22T18:03:33+00:00

30 10, 2018

Avance Biosciences™ Completes Successful FDA Inspection
Gallery

Avance Biosciences™ Completes Successful FDA Inspection

webmaster2026-04-22T18:03:47+00:00

HOUSTON, Oct. 30, 2018 - Avance Biosciences™, Inc., a leading biological testing company supporting drug development and manufacturing, announced today that its Houston facility was inspected by the U.S. Food and Drug Administration on October 01 through October 04, 2018. This inspection focused on the firm’s quality management system, operation procedures, and data integrity, as [...]

Avance Biosciences™ Completes Successful FDA Inspectionwebmaster2026-04-22T18:03:47+00:00

ABOUT US

NEWSLETTER SIGNUP

CONTACT US

RECENT NEWS

CVM GFI #109 (VICH GL15) Effectiveness of Anthelmintics: Specific Recommendations for Equines

Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug

Forms FDA 3542a and FDA 3542: Questions and Answers

Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements: Guidance for Industry and Food and Drug Administration Staff

Certain Postapproval Requirements and Resources for ANDAs

Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing