Well, we’re just four months from the end of FY 2023 and the approval numbers still stand strong. In May, the OGD issued sixty‑three full‑approval actions and eighteen tentative‑approval actions for a total of eighty‑one approval actions. Of the sixty‑three full‑approval actions, six were first‑time generic approvals and thirteen (20.6%) were approved in the first cycle. […]
Well, June got off to a rousing start! In the first fifteen days, the OGD issued forty‑six full‑approval actions and nine tentative‑approval actions. This represents one of the best mid‑month totals (fifty‑five) that we’ve seen in a long time. If the month continues at this pace, we’re likely to see over 100 approval actions for […]
A day or so ago, the FDA released Manual of Policy and Procedure (MaPP) 5021.5 titled Assessment of Facility‑Based Deficiency Major‑to‑Minor Reclassification Requests. A MaPP is a document that informs how the FDA will handle, manage, and prosecute a particular issue internally. In this case, it describes how the FDA will adjudicate a request to […]
Innovators often discontinue products when they are no longer profitable. And, as we all know, to file an ANDA as a duplicate of an approved NDA product, the ANDA applicant must refer to a Reference Listed Drug (RLD) approved for safety and efficacy under section 505(c) of the Act. There are times when an ANDA […]
How do you stop a drug shortage? Make it profitable for more than one, two, or even ten generic companies to sell the drug. History has shown that when five (5) or more players enter a generic field, the drug price drops substantially. Have more than 5-7 players – the price drops to 80% of […]
In a complete supply chain, one site’s lag measure is another site’s lead measure. As important as data integrity is to product quality decisions at the site, data risks in the supply chain can affect availability of product to patients. As mentioned in a previous Lachman blog (here), drug shortages are the preeminent risk for […]
A few days ago, the FDA published a guidance document titled Cover Letter Attachments for Controlled Correspondence and ANDA Submissions (see here) that describes three checklist attachments for various types of ANDAs and related submissions. The checklists are identified as being voluntary, but the OGD suggests that not only can they aid applicants in ensuring […]
Many of our clients and readers have NDAs, ANDAs, and supplements that are still pending approval due to a “complex regulatory issue” where the FDA has missed its goal date; in some cases, this missed date was many months ago. There can be several reasons for this type of delay but, as we have blogged […]
Prescription Medication Information (PMI) will, if FDA has its way, replacing medication guides and other information provided to patients. The goal of the new PMI is to “highlight essential information that the patient needs to know about the prescription drug product and basic directions on how to use the product. The pre-publication of the proposed […]
We are pleased to announce that Lachman Consultants (Ireland) will participate in this year’s MedTech Forum as a Gold sponsor. Held from May 30 – June 1, 2023, in Dublin, Ireland, the three-day event is the largest health and medical technology industry conference in Europe. The Lachman Consultants team will be represented by: Frances Zipp, […]
