FDA has published draft guidance on Forms FDA 3542a and FDA 3542, clarifying requirements for Orange Book patent listings, electronic patent submissions, and the management of patent information throughout the medicinal product lifecycle.

FDA has published draft guidance on Essential Drug Delivery Outputs (EDDOs) for drug delivery devices and combination products. Learn how the recommendations may impact design controls, verification, validation, and change management activities.

The FDA has updated its draft guidance on medical device manufacturer communications with payors, health economic information, and investigational products.

The FDA has released eSTAR Version 7.0, integrating new Human Factors content and expanding PreSTAR capabilities. Learn how these changes may affect medical device manufacturers preparing FDA submissions.

FDA has established a new Class II classification with special controls for transcutaneous electrical nerve stimulators (TENS) intended to treat fibromyalgia symptoms, creating a new regulatory pathway for manufacturers.

The FDA has reported 1,284 Breakthrough Device designations and 198 market-authorised Breakthrough Devices as of March 2026. Learn what this means for medical device manufacturers and U.S. market access strategies.

FDA has updated its guidance on unclassified medical devices, adding five additional device types to its 510(k) enforcement discretion policy. Learn what this means for manufacturers and ongoing FDA compliance obligations.

The FDA has adopted ICH M11 CeSHarP, introducing a harmonized framework for clinical trial protocols. Discover the impact on sponsors and global studies.

The FDA has published its final guidance on Human Factors information in medical device submissions, introducing a new risk-based framework and three Human Factors Submission Categories. Learn what manufacturers need to know.

The FDA has released a major update to its Bioequivalence Statistical Guidance, replacing the 2001 version. The new document introduces adaptive designs, modern statistical methods, guidance for highly variable drugs, NTI products, missing data handling and model-based approaches for generic drug development.

The FDA has announced new eMDR system enhancements, including AEMS integration updates, country code validation changes, and IMDRF adverse event code updates impacting medical device manufacturers.

The FDA has released new guidance on postapproval pregnancy safety studies for drugs and biologics, highlighting pregnancy registries, real-world evidence, and postmarketing surveillance expectations for manufacturers.

The FDA has launched a pilot program introducing one-day inspectional assessments across medical products, biologics, clinical research, and food sectors to support more targeted and efficient oversight.

FDA updates MDR adverse event codes under IMDRF 2025. Key changes may impact manufacturer reporting, vigilance systems, and data consistency.

FDA releases draft guidance proposing reduced regulatory requirements for certain NIOSH-approved respirators. Understand the impact on medical device manufacturers.

FDA opens consultation on a pilot program to assess artificial intelligence in early-phase clinical trials, focusing on efficiency, safety, and decision-making.

FDA releases draft guidance on next-generation sequencing (NGS) for genome editing safety assessment. Key implications for gene therapy manufacturers and IND submissions.

The FDA has replaced the WebTrader system with the ESG NextGen portal for eMDR submissions. Learn what this means for medical device manufacturers and reporting obligations under 21 CFR Part 803.

FDA issues new guidance on biomarker validation. Learn key requirements and what manufacturers must consider for global regulatory compliance.

FDA releases SOPP 8001.4 v9 on proprietary name review for biologics. Key implications for manufacturers and global regulatory strategy.