Search results for Fda Guidance

FDA Issues Guidance on Protein Quality Testing for Infant Formula

The guidance was developed to help manufacturers and laboratories in the design, conduct, evaluation, and reporting of Protein Efficiency Ratio (PER) studies.

New guidance for infant manufacturers available

The FDA has issued final guidance for manufacturers of infant formula and laboratories conducting testing on infant formula. The guidance was developed to help manufacturers and la...

Dietary Supplement Companies, Natural Medicine Group Sue FDA Over Health Claims

A group of dietary supplement companies, joined by an alternative medicine advocacy group, sued FDA (Law360 subscription required) for allegedly violating First Amendment commercia...

FDA’s Human Foods Program Research Needs Include Assessing Nanoparticles

The U.S. Food and Drug Administration’s (FDA) Human Food Program (HFP) has prepared a list of priority research, data, and method needs that, if fulfilled, will help FDA better und...

FDA Issues Recommendations for the Development of Individualized Therapies for Patients With Ultra-Rare Diseases

As discussed previously (“New FDA Guidance Allows Biosimilar Applicants to Use Data From Outside the U.S. To Accelerate Their Approval in the U.S.”), the U.S. Food and Drug Adminis...

FDA Finalizes Post-Market Assessment Program

On May 12, 2026, FDA announced that the Agency finalized its new “proactive food chemical safety post-market assessment program” and launched reassessments of butylated hydroxytolu...

FDA Finalizes Systematic Post-Market Food Chemical Review Process

The agency also announced the launch of reassessments for butylated hydroxytoluene (BHT) and azodicarbonamide (ADA).

FDA Releases Final Documents for Food Chemical Safety Post-Market Assessment Program, Launches Reassessment of BHT and A...

The U.S. Food and Drug Administration announced on May 12, 2026, “two decisive actions focused on food chemical safety.” First, FDA released two final documents for its new proacti...

FDA Issues Draft Guidance on Safety Testing for Gene Editing Therapies

On April 14, 2026, the United States Food and Drug Administration (“FDA”) issued a draft guidance for sponsors seeking approval of human gene-editing therapy products involving gen...

FDA Supports Grouping Several Phthalates for Cumulative Risk Assessment

FDA published a literature review on the eight phthalates currently approved for food contact uses to determine whether they should be considered chemically and/or pharmacologicall...

New York law designed to make facts about food chemicals available to the public

Federal law allows food companies to use chemicals designated as Generally Recognized as Safe (GRAS) without having them subject to review by the Food and Drug Administration. The...

FDA warns New York firm for failing to verify safety of imported foods

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until...

GRAS, additives, chemicals: Who should hold the authority?

-- OPINION --State leadership vs. a patchwork of regulations sums up of the controversy over the “FRESH Act” in a single phrase.Due to its controversial provisions on federal food...

FDA Infant Formula Testing Confirms Safety of U.S. Supply

On April 29, 2026, the U.S. Food and Drug Administration (FDA) announced the results of the largest and most comprehensive testing program ever conducted on infant formula sold in...

FDA confirms safety of U.S. infant formula supply 

The Food and Drug Administration April 29 announced results from its testing of more than 300 infant formulas, finding that the majority of samples had undetectable or very low lev...

FDA To Review Whether To Allow More Access To Certain Peptides

FRIDAY, April 17, 2026 — The U.S. Food and Drug Administration (FDA) will soon review whether certain peptides should be allowed in customized medications made by compounding phar...

FDA Authorizes Glas Flavored ENDS Products, Opening an Age-Gating Pathway for Flavors

On May 5, 2026, the U.S. Food and Drug Administration (FDA) issued marketing granted orders (MGOs) for four Glas closed-pod electronic nicotine delivery system (ENDS) products: Cla...

Congress to Hold Legislative Hearing on 28 Active Bills Related to Food Safety, FDA

The bills to be discussed address issues like “Generally Recognized as Safe” (GRAS) determinations, food chemical safety reassessments, food labeling, infant formula and baby food...

Regulatory Overview: Post-Approval Changes to Marketed Drugs

The popularity of GLP-1s have brought post-approval changes to New Drug Applications (NDAs) to centerstage. Recently, the FDA approved Wegovy in tablet form, offering an alternativ...

Codex Moves to Adopt Standardized Precautionary Allergen Labeling, Kicks UPFs Can Down the Road

During the 49th Meeting of the Codex Committee on Food Labeling (CCFL49), guidelines on risk-based precautionary allergen labeling, labeling for multipack foods, and emergency flex...

FDA’s New ENDS and Nicotine Pouch Enforcement Guidance: Lower Priority for Post-November 2021 Reviewable Applications, H...

On May 8, 2026, the U.S. Food and Drug Administration (FDA) issued final guidance describing how the Agency intends to prioritize enforcement for certain unauthorized electronic ni...

FDA warns three importers for failing to verify safety of imported foods

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until...

FDA to weigh easing limits on unproven peptides promoted by RFK Jr.

The Food and Drug Administration will hold a meeting this summer to consider easing restrictions on more than a half dozen peptide injections, a group of unapproved therapies that...

<![CDATA[FDA Extends Priority Review of Leqembi Iqlik Subcutaneous Injection ]]>