📋FDA Announces Approved Information Collections Impacting Businesses
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Learn More💊FDA Approves Previously Withdrawn NDA for Wellcovorin Tablets
The Food and Drug Administration (FDA or Agency) is announcing approval of the previously withdrawn new drug application (NDA) for Wellcovorin (leucovorin calcium) tablets, equivalent to (EQ) 5 milligrams (mg) base and EQ 25 mg base. FDA is initiating this action on the basis of new data and is required to publish notice of approval of an NDA for which the Agency had previously withdrawn approval.
Learn More💊FDA Releases Draft Guidance for Malaria Drug Development
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Malaria: Developing Drugs for Treatment." The purpose of this draft guidance is to assist sponsors in the overall development program for drug and biological products for the treatment of malaria, caused by clinically relevant Plasmodium species.
Learn More📋FDA Guidance on Safety Labeling Changes for Drug Products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Safety Labeling Changes--Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act." This draft guidance provides information on the implementation of the statutory provision that authorizes FDA to require application holders for certain drug and biological products to make labeling changes based on new safety information that becomes available after approval of the drug that FDA determines should be included in the labeling of the drug. This guidance is being updated and reissued in draft to, among other things, include the addition of information related to Congress' 2018 changes to the definition of adverse drug experience regarding reduced effectiveness and make other changes to reflect current Agency processes and procedures regarding safety labeling changes. This draft guidance revises and, when finalized, will replace the guidance for industry entitled "Safety Labeling Changes--Implementation of Section 505(o)(4) of the FD&C Act" issued in July 2013.
Learn More💊FDA Draft Guidance for sGERD Drug Development
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment." The draft guidance details FDA's recommendations on the clinical trials for drugs being developed for the treatment of symptomatic nonerosive gastroesophageal reflux disease (sGERD) in adults, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments.
Learn More💊Notice of Investigation on Drug Patent Complaint Amendment
Notice is hereby given that the U.S. International Trade Commission ("Commission") has determined not to review an initial determination ("ID") (Order No. 15) of the presiding Chief administrative law judge ("Chief ALJ") granting Complainant's motion to amend the complaint and notice of investigation.
Learn More💉FDA Guidance on Therapeutic Protein Biosimilars
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations." This guidance describes the Agency's recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product licensed under the Public Health Service Act (PHS Act). Additionally, this guidance is intended to provide recommendations to sponsors on the scientific and technical information for the chemistry, manufacturing, and controls (CMC) portion of a marketing application for a proposed product submitted under the PHS Act. This guidance finalizes and replaces the draft guidance of the same title issued on May 22, 2019, and replaces the final guidance "Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product" issued on April 30, 2015.
Learn More💊FDA Reopens Comment Period on Bioequivalence Guidance for Industry
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the draft guidance announced in the notice entitled "M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver; International Council for Harmonisation; Draft Guidance for Industry," published in the Federal Register of June 2, 2025. The Agency is taking this action to allow interested persons additional time to submit comments.
Learn More💊FDA Corrects Drug Approval Notice for Bausch & Lomb and Others
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on March 14, 2025 (90 FR 49), appearing on page 12163 in FR Doc. 2025-04106. The document announced the withdrawal of approval of eight abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of April 14, 2025. The document indicated that FDA was withdrawing approval of the ANDA 075819 for amantadine hydrochloride syrup, 50 milligrams/5 milliliters, held by CMP Pharma, Inc., 8026 East Marlboro Rd., P.O. Box 147, Farmville, NC 27828. Before FDA withdrew the approval of this ANDA, CMP Pharma, Inc., 8026 East Marlboro Rd., P.O. Box 147, Farmville, NC 27828, informed FDA that they did not want the approval of the ANDA withdrawn. Because CMP Pharma, Inc., timely requested that approval of the ANDA not be withdrawn, the approval is still in effect. This notice corrects this error.
Learn More💊FDA Determines NUTRACORT Gel Not Withdrawn for Safety Reasons
The Food and Drug Administration (FDA or Agency) has determined that NUTRACORT (hydrocortisone) topical gel, 1%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for NUTRACORT (hydrocortisone) topical gel, 1%, if all other legal and regulatory requirements are met.
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