USA – Drugmakers Make Significant Headway in Track-and-Trace Compliance
A new GS1 Healthcare report on the progress made in meeting the serialization requirements of the Drug Supply Chain Security Act (DSCSA) found significant progress, especially...
USA – Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of...
This document is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterized cell lines of human or animal...
USA – GAO Raises Questions on FDA’s Orphan Drug Designation Process
The Government Accountability Office (GAO) announced Friday that it has found that the US Food and Drug Administration (FDA) does not always ensure that...
USA – FDA Finalizes Combo Product Postmarket Safety Reporting Guidance
The US Food and Drug Administration (FDA) on Monday finalized guidance explaining postmarket safety reporting (PMSR) requirements for combination products and their constituent parts.
"In...
USA – FDA Announces Plans for Advancing Cell and Gene Therapies
In anticipation of a surge of investigational new drug applications for cell and gene therapies in the next few years, FDA Commissioner Scott Gottlieb...
USA – 3 More NDAs Will Become BLAs
As some insulin, human growth hormone and other products transition on 23 March from new drug applications (NDAs) to biologics license applications (BLAs), the...
USA – FDA report details how agency supports generic-drug development
The US Food and Drug Administration (FDA) on Tuesday released a report detailing the scientific research carried out and funded by the agency in...
USA – FDA Discusses RWD, RWE With Industry, Academia
Industry, academia and US Food and Drug Administration (FDA) officials gathered Friday in Bethesda, MD to discuss the use of real-world data (RWD) and...
USA – FDA has little authority to control quality of foreign-made APIs
Following major recalls of Chinese-manufactured medication that contained carcinogenic ingredients, Congress is taking a hard look at the U.S. supply chain of generic drugs.
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USA – Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the...
This guidance is intended to assist sponsors who are developing biological products, sponsors of biologics license applications (BLAs), and other interested parties in providing...
