Yesterday, we published a blog (here) regarding the newly issued and revised PSGs. I pointed out one example of something that I hadn’t seen before relative to products subject to ANDA suitability petitions. I thought I’d missed something along the way, but I’m glad to say that, no, I did not! In an email today […]
The OGD posted 29 new and 31 revised product-specific guidances (PSGs) today (see here). The new list of PSGs covers drugs with various dosage forms including tablets, capsules, gels, oral suspensions, intramuscular extended-release suspensions, topical solutions, powders, ointments, other parenteral products and orally disintegrating tablets, and subcutaneous extended-release suspensions. One of the new PGSs for […]
Turkey month has two holidays baked into the calendar and that will likely have some impact on approvals reported this month, especially since the Thanksgiving holiday usually is a super short week, as people take multiple days off! Looking at where the unofficial metrics stand, as of today, the OGD has issued 30 full approval […]
I remember being locked in for protection at the Parklawn Building at the FDA in the face of protests outside centering on the AIDS crisis and lack of speed in the approval of antivirals as the first time that I felt as though the FDA was really under attack. Obviously, the FDA came through in […]
The Food and Drug Administration is advising consumers not to purchase or use the following products that are marketed as dietary supplements as they contain undeclared drug products that could be harmful: VITAFER-L Gold 10 ml may be harmful due to hidden drug ingredient tadalafil VITAFER-L Gold 20 ml may be harmful due to hidden drug ingredient […]
Today’s Federal Register pre-publication page contains a notice that is likely the final punch before the oral decongestant phenylephrine lies knocked out on the canvas. The notice (here) states in regard to the “proposed revision of the proposed order OTC000036 to amend the requirements for cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter […]
The new 2025 Fiscal Year (FY) looks like it is off to a great beginning with OGD unofficially issuing 61 full approval actions and 22 tentative approval actions for a total of 83 total approval actions. While the numbers look good, it should be noted that the only month in FY 2024 that had more […]
Baxter Recovery and FDA Actions The FDA announced additional actions “to increase access to and supply of IV and peritoneal dialysis (PD) solutions following Hurricane Helene-related damage to Baxter International Inc.’s North Cove facility in Marion, North Carolina.” The FDA performed assessments to enable import of IV solutions and PD solutions from seven different Baxter […]
A pre-publication Federal Register notice today (here) announced the first group of product-specific guidances (PSGs) for which the requirement for a fed, in-vivo bioequivalence (BE) study has been removed. In some instances, the fasting, in vivo bioequivalence requirements were modified such that now only one in vivo study will be required to support a bioequivalence […]
On the last day of GRx+Biosims, David Gaugh, Executive Vice President of AAM, had a fireside chat with Robert Califf M.D., commissioner of the Food and Drug Administration. The Commissioner’s comments echoed many of the themes discussed by other industry and FDA participants during the meeting, especially regarding the worry about sustainability of the generic […]
