Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments

The Food and Drug Administration (FDA or the Agency) is announcing the following public meeting entitled “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.” The topic to be discussed is the financial transparency and efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.

Determination That NALFON (Fenoprofen Calcium) Oral Capsules, Equivalent to 300 Milligram Base, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria Web Page; Request for Comments

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of the Agency’s annual compilation of notices of updates to the Agency’s Susceptibility Test Interpretive Criteria web page. The Agency established the Susceptibility Test Interpretive Criteria web page on December 13, 2017, and since establishment has provided updates to both the format of the web pages and the susceptibility test interpretive criteria identified and recognized by FDA on the web pages. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).

Joint Statement of the 11th ASEAN Finance Ministers’ and Central Bank Governors’ Meeting (AFMGM)

The 11th ASEAN Finance Ministers’ and Central Bank Governors’ Meeting (AFMGM) was convened under the co-chairmanship of H.E. Mr. Santiphab Phomvihane, Finance Minister and H.E. Mr. Bounleua Sinxayvoravong, Governor of the Bank of the Lao PDR. ASEAN Chair 2024 Priorities The Meeting welcomed Lao PDR’s … Continue reading Joint Statement of the 11th ASEAN Finance Ministers’ and Central Bank Governors’ Meeting (AFMGM)

Request for Nominations for Voting Members for the Patient Engagement Advisory Committee

The Food and Drug Administration (FDA or the Agency) is requesting nominations for voting members, excluding consumer and industry representatives, to serve on the Patient Engagement Advisory Committee (the Committee) in the Center for Devices and Radiological Health. Nominations will be accepted for upcoming vacancies effective with this notice. FDA seeks to include the views of members of all gender groups, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

Request for Nominations on Device Good Manufacturing Practice Advisory Committee

The Food and Drug Administration (FDA or Agency) is requesting that any industry organization interested in participating in the selection of a nonvoting industry representative to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to fill an upcoming vacancy on DGMPAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for an upcoming vacancy effective with this notice.

Determination That GLUCOTROL (Glipizide) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that GLUCOTROL (glipizide) tablets, 5 milligrams (mg) and 10 mg, were 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 these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements.

Robert Lance Shuffert: Final Debarment Order

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Robert Lance Shuffert 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. Shuffert was convicted of one felony count under Federal law for, with the intent to defraud and mislead, causing a drug to be misbranded while it was held for sale after shipment in interstate commerce. The factual basis supporting Mr. Shuffert’s conviction, as described below, is conduct relating to the importation into the United States of any drug or controlled substance. Mr. Shuffert was given notice of the proposed debarment and an opportunity to request a hearing to show why he should not be debarred. As of March 4, 2024 (30 days after receipt of the notice), Mr. Shuffert had not responded. Mr. Shuffert’s failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.