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 […]
The 2024 MedTech Conference in Toronto provided some great insights on what the future of medical devices can offer, particularly when utilizing AI technology. One area making great progress is the use of wearables. Who knew my Apple watch could be so useful?! There were multiple presentations on pairing wearable devices with mobile apps. This […]
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 […]
As Bob has previously blogged on the highlights from AAM day by day, let me take a moment to dive a bit deeper into one of the sessions. As an attendee of this meeting for several years, one of the best things about AAM’s GRx+Biosims is that sessions at this meeting often offer a mix […]
It is the last day of the conference, and we have some highlights for you. In a keynote address, Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, Center for Drug Evaluation and Research provided a State of the Biosimilars and Generics Program. By the numbers she indicated that in Fiscal Year (FY) 2024 OGD: Has […]
