Typically, when the FDA issues a labeling safety warning, it means that a new warning is being added to existing labeling. However, in an FDA safety notice published today titled FDA Requests Removal of Suicidal Behavior and Ideation [SI/B] Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications (here), the FDA is advising GLP-1 RA […]
The International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) endorsed a new draft guidance on extractables and leachables in August 2025 that the FDA has since published for review and comment. The version published by the FDA is accessible at Q3E Guideline for Extractables and Leachables and includes Supporting Documentation: […]
In December, the third month of FY 2026, the number of unofficial approval actions fell significantly from those in the first two months, with the OGD issuing 41 full-approval actions and 13 tentative-approval actions for a total of 54. * December numbers are unofficial but should be close to final. The reasons are not obvious as […]
The official November 2025 OGD statistics are in the books and, as far as approvals are concerned, the OGD had a good month with 58 full approvals and 26 tentative approvals reported. Of the 58 full approvals, 6 were for first-time generics; however, only 6 (10%) were first-cycle approvals. This is one of the lowest […]
Why Using Full-Scale Deflection Introduces Data Integrity Risks In pharmaceutical manufacturing, Accuracy is a critical ALCOA+ principle that can sometimes get lost, particularly when assessing the holistic system. The field instrument level needs to be adequately integrated into the overall assessment, especially in aseptic manufacturing environments where sterilization is critical (and accurate data, such as […]
The FDA reports 27 full-approval actions and 9 tentative-approval actions through December 17, 2025 as posted on its daily (here) and all approvals (here) pages. This total of 36 full- and tentative-approval actions appears to be on the average side and, with the holiday coming up and the number of employees likely absent for vacation, it […]
In an email announcing the two new guidances, the FDA said, “[t]he first guidance titled Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices is intended for investigators, industry, and institutional review boards (IRBs). This final guidance provides recommendations to help clinical investigators comply with the safety reporting requirements for investigational new drug application […]
New MaPP 5200.11 (here) provides an outline of internal FDA policy applied when an NDA product makes a full OTC switch. A partial OTC switch means there is a “leave behind” indication in the NDA product that still requires a prescription. This can be a use, a dose, or a related disease state. This MaPP […]
November 2025 output picked up as the OGD issued 59 full-approval actions and 25 tentative-approval actions in the month. The total of 84 approval actions is the highest since June 2025 when the OGD issued 89 approval actions. It’s also an improvement over October 2025’s output of 75, the first month of the new fiscal […]
Today, the FDA issued 44 new and 37 revised draft product specific guidances (PSGs) outlining FDA’s current thinking on the requirements for establishing bioequivalence to reference listed drugs or reference standards. None of the guidance documents were finalized in the current listings. According to the FDA Email, the 81 guidance documents included (and yes, I […]
