Business · 24/10/2022Updated: 10/17/2026 · 1 min read

Miles Laboratories Inc. Faces FDA Proposal to Withdraw Approval of Alcohol and Dextrose Injection ANDA

Summary

The FDA is proposing to withdraw approval of an abbreviated new drug application for Alcohol and Dextrose Injection, a 5mL/100mL, 5g/100mL formulation, due to the ANDA holder's repeated failure to file required annual reports, and is offering Miles Laboratories Inc. the opportunity to request a hearing on this proposal.

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 · 10/5/2026

CDC Requests Public Comment on Respiratory Protective Devices Data Collection

The Centers for Disease Control and Prevention (CDC) is seeking public input on a proposed data collection project related to Respiratory Protective Devices, as required by the Paperwork Reduction Act of 1995, to inform the approval certification activities under 42 CFR part 84.

Read summary →

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

CMS Approves DNV Healthcare USA Inc. for Continued Hospital Accreditation Program Approval

The Centers for Medicare and Medicaid Services (CMS) has approved DNV Healthcare USA Inc. (DNV) for continued recognition as a national accrediting organization for hospitals participating in Medicare and Medicaid programs.

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

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 →