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Stay current with all the latest and breaking news from FDA Law Blog. Compare headlines and media bias behind news outlets on stories breaking today.

In total, 42 have been published by FDA Law Blog which Ground News has aggregated in the past 3 months.

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Top FDA Law Blog News

The OTC Fee Fallout: Are Hundreds of Companies Ignoring FDA’s User Fee Requirements?

United States · United States

The OTC Fee Fallout: Are Hundreds of Companies Ignoring FDA’s User Fee Requirements?

Since the U.S. Food and Drug Administration (FDA) launched the Over-the-Counter Monograph User Fee Program (OMUFA) in 2020, the Agency has been pushing for modernization and self-funding of its reg…Read Article

Increasing Biosimilar Use Reflects Changing Practice in Pediatric IBD Care

Increasing Biosimilar Use Reflects Changing Practice in Pediatric IBD Care

Pediatric infliximab biosimilar use has risen significantly, reflecting evolving treatment patterns in inflammatory bowel disease (IBD) among children and young adults.See the Story

Controlled Substance Reporting Isn’t Just for DEA Anymore

Controlled Substance Reporting Isn’t Just for DEA Anymore

A memorable Florida Orange Growers’ television ad campaign in the late 1970s proclaimed that “Orange juice from Florida isn’t just for breakfast anymore.” The Federal Controlled Substances Act (“CS…Read Article

The RFD Process: Time for Reform?

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs —The Federal Food, Drug, and Cosmetic Act (FD&C Act) has very different regulatory regimes for pharmaceutical products than devices. Knowing how a product will be regulated is essential to companies. The means to gaining that knowledge for combination products or single entity products where the regulatory classification is unclear is the Request for Designation (RFD). A…Rockville, Maryland · Rockville Read Article

FDA Issues Proposed Order to Facilitate Minor Changes to Solid Oral Dosage Forms to OTC Monograph Drugs, but Such Changes May Come at a Price

On June 5, 2025, FDA announced two proposed monograph orders: 1) Proposed order OTC000038 proposes to make it easier to make (minor) changes to solid oral dosage forms not currently permitted under…Rockville, Maryland · Rockville Read Article

FDA to offer faster drug reviews to companies promoting ‘national priorities’

66% Center coverage: 63 sources

FDA · United States See the Story

DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

By Larry K. Houck —Special Surveillance List of Chemicals, Products, Materials and Equipment Updated A “laboratory supply” is any List I or List II chemical, or any chemical, substance, or other item on a special surveillance list published by the Attorney General (delegated to the Drug Enforcement Administration (“DEA”)) of chemicals, products, materials, or equipment used in the illicit manufacture of controlled substances and listed chemicals…DEA · United States Read Article

Clinical Research Representation: Pass it On

Thirty two years ago today, on June 10, 1993, Congress passed the landmark National Institutes of Health (NIH) Revitalization Act to remedy historical exclusion of women and minorities from researc…FDA Read Article

FTC Rejects Meta’s Accusation of Biased Economics Expert in Antitrust Trial - USA Herald

The Federal Trade Commission (FTC) on Friday urged a Washington, D.C. federal judge to reject Meta Platforms Inc.’s attempt to strike the testimony of the agency’s lead economics expert, dismissing Meta’s accusation of bias as unfounded and without legal merit. In an opposition brief filed with the court, the FTC criticized Meta for avoiding the substantive issues of the case by launching “personal attacks and misdirection” against New York Univ…FTC · United States See the Story

Time is Money and Money is Time…What is an SBD Worth?

We have written many posts (here, here, here, and more) about the impact of the reductions in force (RIFs) on various activities across FDA. One area where the RIFs are beginning to have an impact …Money · Silver Spring Read Article

MAHA Analysis Reveals Impact on Drug Scheduling and Abuse-Deterrent Product Development

A recent analysis of the Mandatory Human Abuse Liabilit […] The post MAHA Analysis Reveals Impact on Drug Scheduling and Abuse-Deterrent Product Development first appeared on GeneOnline News. The post MAHA Analysis Reveals Impact on Drug Scheduling and Abuse-Deterrent Product Development appeared first on GeneOnline News.United States · United States See the Story

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