Agency IQ

JANUARY 26, 2024

BY CHELSEY MCINTYRE, PHARMD | JAN 24, 2024 4:09 PM CST Back to the beginning: What does an expiration date mean to the FDA? Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients.

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Agency IQ

NOVEMBER 10, 2023

The delayed enforcement is part of FDA’s finalized guidance, “Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.” . | Cosmetics must also be in compliance with the Fair Packaging and Labeling Act ( FP&L Act ); however, only color additives require FDA approval before they may be used in cosmetics.

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Agency IQ

JUNE 16, 2023

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list.

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Agency IQ

MAY 31, 2024

AdComm votes in favor of new colorectal cancer screening test, but questions about serial testing and labeling remain In May 2024, the FDA’s Molecular and Clinical Genetics Device panel voted 7-2 in favor of the approval of a new blood-based screening test for colorectal cancer, which would be the first blood-based test of this type.

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Agency IQ

DECEMBER 1, 2023

and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. Within 180 days, FDA will release a report on the proceedings of the public meeting and any recommendations.

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Codon

MARCH 24, 2024

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. ” Asimov Press (2024).

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Agency IQ

MARCH 7, 2024

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. Per the budget table , this is actually a (relatively) small decrease for the FDA.

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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Drug & Device Law

DECEMBER 29, 2023

The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law. See you in 2024.

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