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FDA Regulations to Establish Minimum CGMP Requirements for Manufacturing, Packaging, Labeling, and Holding of Dietary Su...

On June 18, 2026, the Food and Drug Administration (“FDA”) announced the submission of a proposed collection of information to the Office of Management and Budget (“OMB”) pertainin...

FDA Issues Draft Guidance Clarifying Use of Form FDA 3542

<![CDATA[FDA Sends CRL to Cingulate for CTx-1301]]>

From Caffeine To 'Healthy' Labeling, FDA Sets Year-End Agenda For US Food Supply

TUESDAY, June 30, 2026 — The U.S. Food and Drug Administration (FDA) has announced the food supply issues it seeks to tackle by year’s end. The FDA’s Human Food Program aims to pre...

FDA warns four importers about safety verification failures

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...

<![CDATA[Pharmaceutical Executive Daily: FDA Approves Datroway]]>

FDA steps up import enforcement action on infant formula, cantaloupes and seafood

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as needed.Re...

At the Half: No Free Kicks in FDA’s 2026 Enforcement

As the World Cup has captured the attention of viewers around the globe, so has the Food and Drug Administration (FDA) when it comes to taking enforcement action against regulated...

<![CDATA[FDA's Timeline for DTC Prescription Drug Ad Oversight]]>

FDA warns Florida supplement maker about sanitation and allergen risks

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

FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients

The U.S. Food and Drug Administration (FDA) today issued draft guidance to help developers bring promising gene therapies to patients more efficiently by making greater use of ex...

FDA Proposes Long-Awaited Rule to Require Foreign Tobacco Manufacturers to Register Establishments and List Products

On June 26, 2026, the U.S. Food and Drug Administration (FDA), Center for Tobacco Products (CTP), announced a proposed rule titled “Establishment Registration and Product Listing f...

United Therapeutics nabs FDA approval for donor-lung assessment device

United Therapeutics has been given a premarket approval from the FDA for its LungFX device.

FDA letter reinforces responsibilities of infant formula supply chain

The FDA has put the entire infant formula supply chain on notice to improve monitoring and production practices.The decree comes amid a second outbreak since November 2025 of infan...

<![CDATA[FDA’s New Pilot Program and Real-Time Review of Clinical Data]]>

<![CDATA[FDA Accepts NDA for Giredestrant in ER-Positive Early-Stage Breast Cancer]]>

FDA approves KetoMed for fever in cattle with BRD

Generic ketoprofen injectable solution receives approval for control of BRD-associated pyrexia in certain beef and dairy cattle.

Clariant secures FDA approval for bio based Licocare RBW additives

Clariant has received US Food and Drug Administration FDA approval for its bio based Licocare RBW wax additives for use in rigid polyvinyl chloride PVC food contact applications

<![CDATA[Pharmaceutical Executive Daily: FDA Approves Utebzi and Capvaxive]]>

Following Infant Formula Incidents, FDA Urges Manufacturers to Implement Stronger, Substantive Supplier Oversight

The letter to industry was issued in response to the botulism outbreaks linked to Nara Organics and ByHeart formulas, which identified Clostridia in the whole milk powder ingredien...

<![CDATA[Pharmaceutical Executive Daily: FDA Approves Xocova]]>

FDA cites three companies for failing to verify safety of a variety of imported products

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...

<![CDATA[The Industry’s Communication and Engagement with FDA]]>

HepQuant nabs FDA premarket approval for liver diagnostic test

The FDA has granted premarket approval to HepQuant’s liver diagnostic test for the treatment of adults with Child-Pugh Class A compensated cirrhosis, according to a company press r...