Business · 07/11/2000Updated: 10/17/2026 · 1 min read

FDA Proposes Changes to Postmarketing Reporting Requirements for Certain Drug Products

Summary

The FDA is proposing to revise its regulations to implement provisions of the 1997 Modernization Act, requiring sole manufacturers of life-supporting or life-sustaining drugs to notify the agency at least 6 months prior to discontinuing production.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

Add your company to Business Communicator

We monitor business sources and connect attention with companies, profiles and services available in Business Communicator.

Create a free company profile Explore businesses on Business Maps →

Create a free company profile →

Explore insights

Business insights →

Healthcare Business News Global Markets News Trade Regulation News Business Technology News Fintech for Business: Payments & Banking News Supply Chain News

Related business signals

Business · 9/17/2026

Proposed Data Collection Activity for Diaper Distribution Demonstration and Research Pilot Beneficiary and Organizational Survey

The Administration for Children and Families, Department of Health and Human Services, is proposing to continue collecting data on diaper need and outcomes for beneficiaries of the Diaper Distribution Demonstration and Research Pilot, with proposed changes to the Beneficiary Survey and addition of an Organizational Survey.

Read summary →

Business · 9/17/2026

FDA Grants Partial Exemption to Medical Devices

The FDA has finalized a rule exempting certain radiology computer-aided detection and diagnosis devices from premarket notification requirements, following a petition filed in 2025 and denied in 2026.

Read summary →

Business · 9/16/2026

NIH Proposed Collection; 60-Day Comment Request; NIH Intramural Reporting of Research Misconduct (IRRM) Web Form

The National Institutes of Health (NIH) is proposing a web-based reporting form to help the Agency Intramural Research Integrity Officer (AIRIO) assess concerns and determine appropriate next steps in evaluating allegations of research misconduct.

Read summary →

Business · 9/16/2026

Food and Drug Administration Announces Proposed Collection of Information for Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing

The Food and Drug Administration (FDA) has submitted a proposed collection of information to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Read summary →

Business · 9/16/2026

Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Pathogen-Agnostic Sequencing

The Food and Drug Administration (FDA) announces a public advisory committee meeting of the Microbiology Devices Panel to discuss pathogen-agnostic sequencing for emergency preparedness and response efforts.

Read summary →

Business · 9/16/2026

Order Under Sections 362 and 365 of the Public Health Service Act Continuing the Suspension of the Right To Introduce Certain Persons From Countries Where a Quarantinable Communicable Disease Exists

The Centers for Disease Control and Prevention (CDC) issued an Order under Sections 362 and 365 of the Public Health Service Act, continuing the suspension of introducing certain persons from countries with a quarantinable communicable disease outbreak.

Read summary →