Government and Regulatory Affairs

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FDA’s Classification of DNA-Based Tests in Hematological Malignancies

May 28, 2025

Explore the intricacies of the FDA's new classification for DNA-based tests measuring minimal residual disease in hematological malignancies. Learn how the shift to Class II with special controls impacts safety, effectiveness, and patient access, reducing regulatory...

FDA’s Class II Classification of FISH Devices

May 28, 2025

Learn about the FDA's critical decision to classify devices for detecting and identifying microbial nucleic acids by FISH into class II, featuring special controls that ensure safety and effectiveness while reducing regulatory burdens. This course covers the...

Government and Regulatory Affairs

FAA Rule: Flight Prohibition Over Libyan Airspace

Patient Protection and Affordable Care Act: Proposed Marketplace Rule Analysis

FAA Proposed Rule: Enhancing Lightning Strike Safety on Airbus A350

FAA Airworthiness Directive Compliance for Airbus A300-600

US Swine Health Improvement Plan: Comprehensive Certification Course

USDA Multifamily Housing Credit Report Process Update

Updated ‘Healthy’ Definition for Food Labeling by FDA

Compliance with Select Agent Regulations for Junín Virus Vaccine

Privacy Act Exemptions for ORR Records

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LATEST Products

FDA’s Classification of DNA-Based Tests in Hematological Malignancies

FDA’s Class II Classification of FISH Devices