News & Analysis as of

Final Guidance Filing Requirements

Hogan Lovells

FDA finalizes 2025 Q-Submission Guidance, streamlining interactions for device sponsors and proposes electronic submission mandate...

Hogan Lovells on

On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” offering an expanded framework...more

Venable LLP

FDA Finalizes Section V of the 2016 Revised Draft NDI Guidance

Venable LLP on

On March 4, FDA announced the availability of a final guidance, Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes – Guidance for Industry. The guidance finalizes Section V: NDI Notification...more

Arnall Golden Gregory LLP

Client Alert for H-1B Employers – Importance: High

Amended H-1B Petitions May be Required Immediately - Applies to: All employers with H-1B employees working at job sites other than those specified in H-1B filing. Action needed now: Verify that actual work site of...more

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