The AAM GRx+Biosims meeting recently concluded, and it was great to see so many familiar faces and to meet individuals in person for the first time. This conference always affords attendees opportunities to hear new insights from FDA leadership and catch up with colleagues. I’m sure that attendees all had a favorite session or discussion, […]
On October 3, 2025, FDA announced a new “ANDA prioritization pilot (which) represents a further step FDA is taking to incentivize U.S. generic drug manufacturing and testing. Under this pilot, ANDA applicants who conduct any required bioequivalence testing in the United States and whose products are made in the U.S. using exclusively domestic sources for […]
While Friday, August 8, 2025 didn’t appear to be different than any other Friday during the summer, it turned out to be a rather momentous date for a few ANDA sponsors. This is because it was the day that the FDA’s Office of Generic Drugs approved three ANDAs for Iron Sucrose Injection as therapeutically equivalent to […]
One recurrent issue that keeps arising in our consulting practice is the impact of pediatric exclusivity on the ability of the FDA to approve applications during a pediatric exclusivity period associated with a listed patent. For those sponsors that are not careful, a pediatric exclusivity period (or successive periods of pediatric exclusivity that are associated […]
As many in industry are already aware, suitability petitions began to be subject to review metrics at the beginning of Fiscal Year 2024, which started on October 1, 2023. As a reminder, the GDUFA III Commitment Letter (GIII CL) requires the FDA to review and respond to suitability petitions that have been assigned a goal date within six […]
The holidays are fast approaching and many of us are in a joyful spirit, more prone to giving and charity in alignment with the season. That said, considering the effort that goes into sponsors’ pursuit of ANDA approvals where the sponsor or sponsors may be eligible for 180-day exclusivity, I doubt that anyone in the […]
For those of us that live in areas with seasonal changes, I’m sure everyone has experienced the telltale signs that autumn is right around the corner. These changes are subtle at first but soon gain significance and portend a future that looks different than the present. Individuals who carefully examine the FDA’s Paragraph IV (PIV) Patent […]
In a recent landmark decision, the Supreme Court struck down what is known as the Chevron decision, a 1984 case that basically gave federal agencies deference in how to interpret statutes that may be somewhat ambiguous or not completely clear. This deference was not, of course, absolute (as we will see later), but, basically, under […]
Any frequent reader of the Lachman blog is well acquainted with the blog’s affinity for commenting on approval metrics from the Office of Generic Drugs (OGD). Today’s blog will also address metrics, but, in this case, the metrics are related to suitability petitions and are completely unofficial as the OGD has yet to publish or […]
As one would expect from a consulting service that focuses primarily on the Regulatory and Compliance sectors, the Lachman Blog has not historically focused on issues that are primarily economic in nature, unless the discussion is related to drug shortages. When searching our blog archive, I only found a single reference to the issue that […]
