In a pre-publication Federal Register Notice (FRN) (here) on FDA’s webpage on Over-The-Counter Monograph Drug User Fee Program (OMUFA) (here), the FDA announced the OTC Monograph User Fees for FY 2027. The Notice explains how the fees were set and the change where “beginning with FY 2027, FDA is consolidating the separate facility fee notices […]
FDA published the FY 2027 GDUFA Fee Rates today (here) and it is mostly good news for the industry. While ANDA fees went up by $17,437 and DMFs popped up another $7,315, all facility fees dropped. This is likely because of a lower number of ANDAs that have been submitted over the past year (580) […]
A significant FDA reorganization is scheduled to be published in the Federal Register on July 29, 2026 (see here). The proposal is one of the most extensive administrative restructurings the agency has undertaken in years and is intended to “centralize and enhance key functions across the agency” to “reduce redundancies, improve efficiency, and advance alignment […]
Usually, every quarter, the FDA issues a series of new and revised product specific bioequivalence guidances designed to provide the industry with FDA’s current thinking on the appropriate methods to establish bioequivalence of certain products. Today, FDA issued a list (here) composed of only newly revised guidances and all of them are for injectable peptide […]
Today, the FDA approved a combination of acetaminophen and naproxen sodium tablets, 325 mg/110 mg for minor pain as an over-the-counter product for 12-hour pain relief. FDA says in a press release (here): “This nonprescription product is indicated for the temporary relief of minor aches and pains due to headache, backache, muscular aches, toothache, menstrual […]
Everyone in the generic drug industry was shocked by the announcement that President Trump will impose 100% tariffs in 2028 and then increase them to 200% the year after for companies that do not onshore generic production. What does this mean? Unfortunately, we won’t know for a while as there are no details regarding the […]
Artificial intelligence is transforming virtually every industry, from healthcare and pharmaceuticals to finance and national security. Yet as adoption accelerates, so does evidence of harm. The Organization for Economic Co-operation and Development (OECD) AI Incidents Monitor (AIM), which tracks publicly reported AI incidents and hazards worldwide now contains more than 16,000 documented incidents and hazards, […]
Have you assessed the strategic risk of your company’s readiness to meet the following regulation in the future? “Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions (21 CFR 211.25(a))” Or […]
In the pharmaceutical industry, some of the most important regulatory expectations are not always found in the main body of a guidance document. Occasionally, a seemingly modest footnote carries significant implications for the future of compliance. One such example appears in the MHRA GxP Data Integrity Guidance and Definitions (March 2018), which states: “It is […]
With the World Cup now behind us and Spain crowned the new champion of the soccer world, it is time to get back to business as usual! The first half of July saw the Office of Generic Drugs issue 28 full approval actions and 3 tentative approvals for a total of 31 approval actions for […]
