I remember working part-time as a pharmacist when I was at FDA and there were only a few prescription oral contraceptives that were available for dispensing at that time. If you had asked then (1984) if I thought that there would ever be an OTC version of an oral contraceptive available, I would have bet […]
As we know, many drug products are approved initially only for adult patients. The Pediatric Research Equity Act (PREA) of 2003 “gives FDA the authority to require pediatric studies in certain drugs and biological products. Studies must use appropriate formulations for each age group. The goal of the studies is to obtain pediatric labeling for […]
The ISPE 2023 Biotechnology Conference was held from 26 to 27 June in Dublin, Ireland. Much of the focus of the conference was Cell and Gene Therapy and Advanced Therapy Medicinal Products (ATMPs), terms used in the US and EU for a range of emerging therapies and products in various stages of development. At the […]
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 […]
Join Lachman Consultants (Ireland) in Malta for Medicines for Europe 28th Annual Conference, June 14 – 16. The three-day conference features a series of keynotes and sessions around the actions required to address public health needs and build a healthier Europe. The event will also include a discussion led by Lachman Consultants’ President and CEO, […]
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 […]
