Drugmakers Make Significant Headway in Track-and-Trace Compliance

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...
GAO Raises Questions on FDA’s Orphan Drug Designation Process

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...
Coronavirus delays many FDA foreign inspections

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...
Institutional Review Board (IRB) submissions: Necessary for usability tests?

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...
Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices

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...
Coronavirus delays many FDA foreign inspections

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...
FDA Discusses RWD, RWE With Industry, Academia

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...
FDA finalizes guidance on clinical, in vitro drug interaction studies

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. About...
ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications

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...

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