📊FDA Seeks Comments on Electronic Study Data Submission Standards
The Food and Drug Administration (FDA or Agency) is exploring Clinical Data Interchange Standards Consortium (CDISC) Dataset- JavaScript Object Notation (Dataset-JSON) version 1.1 as a new exchange standard, with the long-term potential to replace Statistical Analysis System (SAS) version 5 XPORT Transport Format (XPT), for submission of electronic study data to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). FDA is requesting comments on whether to accept Dataset-JSON to exchange electronic study data as part of regulatory applications in the future. In particular, FDA is requesting feedback on the risks and benefits of industry adopting Dataset-JSON as a new exchange standard for submitting electronic study data to FDA and any integration challenges with existing tools and systems.
Learn More🌿FDA Extends Comment Period for Poppy Seed Practices
The Food and Drug Administration (FDA or we) is extending the comment period for a request for information on industry practices related to poppy seeds, such as information about growing, harvesting, processing, and distribution of poppy seeds, including industry practices to reduce the opiate alkaloid content of poppy seeds. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments. We intend to use the information to help determine what type(s) of actions, if any, we should take to help ensure that poppy seed products do not pose a health risk when consumed.
Learn More💊FDA Confirms NASCOBAL Status, Impacting Generic Approvals
The Food and Drug Administration (FDA, Agency, or we) has determined that NASCOBAL (cyanocobalamin) nasal spray, 0.5 milligram (mg)/spray, was not withdrawn from sale for reasons of safety or effectiveness.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 Reopens Comment Period for Type VII Veterinary Master File Guidance
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice announcing the availability of a draft guidance for industry (GFI) that appeared in the Federal Register of January 7, 2025. In that notice, FDA requested comments on draft GFI #260 entitled "Type VII Veterinary Master File for Research and Development and Risk Reviews." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments before the agency begins work on the final version of the guidance.
Learn More💊FDA Decision on ETHYOL
The Food and Drug Administration (FDA, the Agency, or we) has determined that ETHYOL (amifostine) for injection, 500 milligrams (mg)/ vial, was 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 Finds VIBRAMYCIN Not Withdrawn, Impacts Generic Drug Market
The Food and Drug Administration (FDA, Agency, or we) has determined that VIBRAMYCIN (doxycycline) for oral suspension, equivalent (EQ) 25 milligrams (mg) base/5 milliliters (mL), was 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 Withdraws Approval for 18 New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 new drug applications (NDAs) from multiple 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 Confirms DECADRON Not Withdrawn for Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that DECADRON (dexamethasone sodium phosphate) solution/ drops, equivalent to (EQ) 0.1 percent phosphate, was 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💊Implications of New Nonprescription Drug Regulations for Businesses
In accordance with the memorandum of January 20, 2025, from the President, entitled "Regulatory Freeze Pending Review," the effective date of the final rule, entitled "Nonprescription Drug Product With an Additional Condition for Nonprescription Use," (ACNU) was delayed until March 21, 2025. Additional time is needed for review; therefore, the delay is extended for an additional 60 days.
Learn More💊FY 2025 Facility Fee Rates for OTC Monograph Drugs Announced
The Food and Drug Administration (FDA, the Agency, or we) is announcing the over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC monograph drug user fee program (OMUFA) for fiscal year (FY) 2025. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests (OMORs). This notice publishes the OMUFA facility fee rates for FY 2025.
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