💊FDA Report on Drug Firms' Postmarketing Requirements and Commitments
The Food and Drug Administration (FDA or Agency) is announcing the availability of the Agency's annual report entitled "Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments." Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to report annually on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological products. The report on the status of the studies and clinical trials that applicants are required to, or have agreed to, conduct is on FDA's website entitled "Postmarketing Requirements and Commitments: Reports" (https://www.fda.gov/drugs/postmarketing- requirements-and-commitments-introduction/postmarketing-requirements- and-commitments-reports).
Learn More🎨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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Replacing Color Additives in Approved or Marketed Drug Products." This draft guidance provides recommendations for replacing color additives in approved or marketed drug products.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 Additionally, this draft guidance recommends that new drug application (NDA) and abbreviated new drug application (ANDA) holders submit information to support color additive replacements in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 Therefore, this draft guidance recommends a CBE-30 for such a change.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 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's Draft Guidance for Electronic Submission of Medical Device Q-Submissions
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Electronic Submission Template for Medical Device Q-Submissions." FDA is issuing this draft guidance to introduce submitters of certain Q-Submissions (Q-Subs), specifically Pre-Submissions (Pre-subs) to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER), to the current resources and associated content developed and made publicly available to support Pre-Sub electronic submissions to FDA. This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. This draft guidance is not final nor is it for implementation at this time.
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.
Learn More🧪FDA Revokes Emergency Use Authorizations for COVID-19 Tests
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Pfizer Inc. for the Lucira COVID-19 All-In- One Test Kit and Lucira CHECK-IT COVID-19 Test Kit, MAWD Laboratories for the MAWD Laboratories SARS-CoV-2 Dual Target by RT-PCR, and Nuclein, LLC (merged with Molecular Diagnostics Inc.) for the DASH SARS-CoV-2/S Test. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.
Learn More🧬FDA Classifies Inherited Nucleotide Repeat Disorder DNA Test
The Food and Drug Administration (FDA, Agency, or we) is classifying the inherited nucleotide repeat disorder DNA test 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 inherited nucleotide repeat disorder DNA test'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 Reopens Comment Period for Sanitation Guidance on Foods
The Food and Drug Administration (FDA or we) is reopening the comment period for a draft guidance entitled "Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: Guidance for Industry," which was announced in the Federal Register of January 7, 2025. We are taking this action in response to requests to allow interested persons additional time to submit comments before FDA begins work on the final guidance.
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