❌FDA Withdraws Approval of 72 Drug Applications - Business Impact
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 72 abbreviated new drug applications (ANDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 Guidance on Computer Software Assurance for Medical Devices
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Computer Software Assurance for Production and Quality System Software." FDA is issuing this guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. FDA believes that these recommendations will help foster the adoption and use of innovative technologies that promote patient access to high-quality medical devices and help manufacturers to keep pace with the dynamic, rapidly changing technology landscape, while promoting compliance with laws and regulations implemented by FDA.
Learn More🐾FDA Announces ADUFA V Third-Party Assessment Report Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a report entitled "ADUFA V Third-Party Assessment Report" and a related virtual public meeting. The purpose of the virtual public meeting is to provide an overview of a third- party assessment that examines the implementation of the Animal Drug User Fee Act (ADUFA). FDA is soliciting comments on the assessment.
Learn More💊FDA Approves Previously Withdrawn NDA for Wellcovorin Tablets
The Food and Drug Administration (FDA or Agency) is announcing approval of the previously withdrawn new drug application (NDA) for Wellcovorin (leucovorin calcium) tablets, equivalent to (EQ) 5 milligrams (mg) base and EQ 25 mg base.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on the basis of new data and is required to publish notice of approval of an NDA for which the Agency had previously withdrawn approval.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 Guidance on In Vitro Diagnostic Tests During Emergencies
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency." This guidance describes the factors FDA intends to assess in deciding whether to issue an enforcement policy regarding in vitro diagnostic test manufacturers' offering of certain unapproved in vitro diagnostic tests and unapproved uses of approved in vitro diagnostic tests during a declared emergency.
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📋Regulatory Changes from HHS
The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.
Learn More🏥Public Workshop on Pediatric Therapeutics and Neonatal Product Development
The Food and Drug Administration (FDA or we) is announcing the following public workshop entitled "Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development--Leveraging Rare Disease Frameworks." The aim of the public workshop is to discuss common challenges in neonatal and rare disease product development and identify opportunities to leverage rare disease product development frameworks in the neonatal product development space.
Learn More💉FDA Notice on Vaccines and Biological Products Advisory Committee Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
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.
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