🎨FDA Guidance on Replacing Color Additives in Drug Products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Replacing Color Additives in Approved or Marketed Drug Products." This draft guidance provides recommendations for replacing color additives in approved or marketed drug products. If a color additive is replaced in a drug product, information to support the change should be retained and available at the manufacturing facility. Additionally, this draft guidance recommends that new drug application (NDA) and abbreviated new drug application (ANDA) holders submit information to support color additive replacements in changes being effected in 30 days (CBE-30) supplements. Although a qualitative or quantitative change to an inactive ingredient is generally considered a major change, in many cases, replacing a color additive with one that is listed in the color additive regulations is unlikely to adversely affect the identity, strength, quality, purity, or potency of the drug product. Therefore, this draft guidance recommends a CBE-30 for such a change.
Learn More🚫FDA Withdraws Approval of Two Drug Applications - Business Implications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of two new drug applications (NDAs) from two applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Learn More🚫FDA Issues 5-Year Debarment Order Against Evan Asher Field
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Evan Asher Field for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Field was convicted of one felony count under Federal law. The factual basis supporting Mr. Field's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Field was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of April 25, 2024 (30 days after receipt of the notice), Mr. Field had not responded. Mr. Field's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Learn More💊FDA Notice on Regulatory Review Period Determination for LOQTORZI
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LOQTORZI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More⚗️FDA Classification of Anti-Mullerian Hormone Test System
The Food and Drug Administration (FDA, the Agency, or we) is classifying the anti-mullerian hormone test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the anti-mullerian hormone test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More💊FDA Determination on COREG CR Drug Approval and Implications
The Food and Drug Administration (FDA, Agency, or we) has determined that COREG CR (carvedilol phosphate) extended-release capsules, 10 milligrams (mg), 20 mg, 40 mg, and 80 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Learn More⚙️FDA Classifies Temporarily-Placed Urethral Opening System
The Food and Drug Administration (FDA, Agency, or we) is classifying the temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the temporarily- placed urethral opening system for symptoms of benign prostatic hyperplasia's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More🦐FDA Issues 5-Year Debarment Order Against Quality Poultry & Seafood
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Quality Poultry and Seafood, Incorporated (QPS) for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that QPS was convicted of a felony count under Federal law for conduct relating to the importation into the United States of an article of food. QPS was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of March 15, 2025 (30 days after receipt of the notice), QPS has not responded. QPS' failure to respond and request a hearing constitutes a waiver of its right to a hearing concerning this matter.
Learn More🚫FDA Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Justin Cole Henry for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Henry was convicted of a felony under Federal law for possession with intent to distribute a Schedule III controlled substance. The factual basis supporting Mr. Henry's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Henry was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of February 24, 2025 (30 days after receipt of the notice), Mr. Henry had not responded. Mr. Henry's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Learn More🌿FDA Notice on Poppy Seeds Regulation and Comment Period Extension
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on April 9, 2025. The document announced the extension of the comment period for the request for information entitled "Growing, Harvesting, Processing, and Distribution of Poppy Seeds--Industry Practices Related to Opiate Alkaloids." The notice published with an error in the ADDRESSES section. This document corrects the error.
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