We previously noted that April would likely be a good month for OGD approvals, and it was! The OGD approved 85 ANDAs, of which 41were first-time generics; however, only 10 (11.7%) were first-cycle approvals. This low percentage of first-cycle approvals is likely because of the large number of single-entity and combination dapagliflozin products that were approved […]
FDLI’s 2026 annual conference covered several industry hot topics, with a particular focus on AI and how the FDA is leveraging technology and existing resources to improve efficiency and engage with industry. Although progress appears to be on the horizon, industry should remain mindful of the FDA’s current structural limitations and the ongoing need for […]
Dr. Marty Makary resigned today as FDA Commissioner, marking another leadership transition for an agency that continues to face pressure across drug reviews, inspections, compliance, and broader public health policy. For pharmaceutical and biotech companies, changes in FDA leadership always raise questions about regulatory priorities, review timelines, and enforcement focus. While leadership shifts can influence […]
I had the good fortune to attend the FDLI Annual Meeting held on May 6th and 7th. The FDLI Annual Meeting is always a good conference where attendees are able to hear many great updates from the FDA and insights on issues related to our industry. This year was no exception, and the FDA had a […]
Lachman Consultants is attending the TIDES USA 2026 conference this week in Boston, one of the premier events focused on oligonucleotide and peptide therapeutics, CMC, manufacturing, quality, and regulatory strategy. As the biopharmaceutical industry continues to advance innovative modalities and complex therapies, TIDES provides an important forum for collaboration, technical insight, and regulatory discussion across […]
The Coming Wave of GLP-1 Competition The global success of GLP-1s has reshaped the metabolic disease landscape, driving unprecedented demand across diabetes, obesity, and adjacent indications. As key patents for leading products (such as semaglutide and tirzepatide) approach expiration in various countries, a new wave of companies, ranging from traditional generics manufacturers to complex peptide […]
In today’s pharmaceutical environment, remediation following FDA enforcement action has become more complex, data-driven, and scrutinized than ever before. Recent trends, including a holistic view and an increased focus on data integrity, digital system validation, supply chain oversight, and quality culture, have raised the bar for what constitutes an effective and sustainable remediation program. Companies […]
What began as a concept previewed earlier this year has now become official policy. Today, the U.S. Food and Drug Administration (FDA) announced the launch of its “One-Day Inspectional Assessments” program, formalizing a new inspection model aimed at certain low-risk facilities (here). Under the initiative, qualifying sites may undergo a streamlined, single-day inspectional assessment while […]
While April showers may bring May flowers, the number of unofficial April ANDA approvals sure is a welcome event. April saw full approval of 87 ANDAs, the highest number since August 2023 when the FDA approved 98. April’s total was bolstered by the 24 full approvals of dapagliflozin single entity and combination products on April 6th. […]
Today, the FDA sent out a PDUFA Dear Colleague letter (here) asking firms to verify program fee assessment information that the Agency has relative to applications covered under PDUFA VII. The letter states that “[u]nder PDUFA VII, a program fee is assessed annually for certain prescription drug products identified in a human drug application approved as of […]
