💊FDA Notice on ALTUVIIIO Patent Extension and Review Period
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ALTUVIIIO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 Notice on Regulatory Review Period for VELSIPITY Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VELSIPITY 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 drug product.
Learn More💊FDA Notice on BREYANZI Regulatory Review Period and Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BREYANZI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 Regulatory Review Period Determination for TRUQAP
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TRUQAP and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 drug product.
Learn More🦪FDA Notice on Interstate Shellfish Dealer's Certificate Compliance
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Learn More💊FDA Determines Regulatory Review Period for ZILBRYSQ Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZILBRYSQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 drug product.
Learn More💊FDA Notice on Patent Extension for EXEM FOAM
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EXEM FOAM 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 drug product.
Learn More💊Guidance on Post-Warning Letter Meetings Under GDUFA
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Post- Warning Letter Meetings Under GDUFA." This guidance provides information on the implementation of the Post-Warning Letter Meeting process for certain drug manufacturing facilities, a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to the reauthorization of the Generic Drug User Fee Amendments (GDUFA), as described in "GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027" (GDUFA III commitment letter). Specifically, this guidance describes the process detailed in the GDUFA III commitment letter for how an eligible facility may request a Post-Warning Letter Meeting with FDA regarding the facility's ongoing remediation efforts to address current good manufacturing practice (CGMP) deficiencies described in a warning letter, how to prepare and submit a complete meeting package, and how FDA intends to conduct the Post-Warning Letter Meeting.
Learn More💊FDA Determines Regulatory Review Period for QALSODY Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for QALSODY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 drug product.
Learn More💊FDA Advisory Committee on REXULTI
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs 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.
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