FDA Authorizes PMTA for First Flavored ENDS Products Other Than Menthol and Tobacco
May 5, 2026 Yesterday, the U.S. Food and [...]
Industry Insight: What is Breakthrough Device Designation for Medical Devices?
What is the Breakthrough Device Program? The FDA’s Breakthrough [...]
FDA Stalls Nicotine Pouch Fast-Track Program Over Youth Adoption Concerns
On April 1, a report by Reuters stated that [...]
FDA Launches New Adverse Event Look-Up Tool
At a Glance: The FDA [...]
FDA Clarifies Evidence Expectations for PMTAs of Flavored Products
March 9, 2026 On March [...]
Accorto Regulatory Solutions Launches Dedicated Quality & Compliance Division
Richmond, Virginia - February 2, 2026 [...]
From QSR to QMSR: Understanding FDA’s Alignment with ISO 13485
January 26, 2026 The Quality [...]
Navigating FDA’s Pre-Submission Process: Strategies for Effective Early Regulatory Engagement
October 10, 2025 For medical [...]
FDA’s Final Guidance on Computer Software Assurance: A New Era for Medical Device Manufacturing
September 26, 2025 On September [...]
FDA Issues Final Guidance on Enforcement Discretion for In Vitro Diagnostic Tests in Declared Emergencies
September 23, 2025 On September [...]
