HeyJaredHoward Sklamberg
- Indexed articles, last 90 days
- 3
- Latest publication
- Sep 18, 2026
- Outlet visibility, for Mondaq
- Top 500K sites
- Earliest in this view
- Jul 14, 2026
Latest articles
Root Causes: Updates And Insights On Quality And Inspections (opens the original)
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We are happy to launch a new newsletter, Root Causes: Updates and Insights on Quality and Inspections. The newsletter, which will come out roughly monthly, will discuss new developments in FDA inspections and enforcement, and its regulation of manufacturing and clinical trials. We will also discuss occasional developments from overseas regulators, such as in Europe, that affect the U.S. market. Manufacturing and chemistry, manufacturing, and controls (CMC) issues remain at the center of the U.S.
FDA Proposes Mandatory GRAS Notification Requirement (opens the original)
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On August 11, 2026, the U.S. Food and Drug Administration (FDA) published a proposed rule that would convert the currently voluntary Generally Recognized as Safe (GRAS) notification program into a mandatory requirement. If finalized, any person who introduces a substance into interstate commerce based on self-determined GRAS status would be required to notify FDA of the GRAS determination and provide supporting documentation. The notification requirement would apply to products currently on the
FDA Proposes New Registration And Listing Pathway For Distributed Drug Manufacturing And Aligns Foreign Establishment Obligations With Current Law (opens the original)
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On July 13, 2026, the U.S. Food and Drug Administration (FDA) published a proposed rule that would amend the drug establishment registration and drug listing requirements for establishments engaged in distributed manufacturing (DM) and for foreign drug establishments.1 First, it would create a DM-specific registration pathway for distributed manufacturing establishments (DMEs) that meet select criteria. Second, it proposes updates to the drug establishment registration and drug listing requireme
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Top 500K sites
For Mondaq, the outlet · Measured Aug 1, 2026
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