The FDA released a guidance yesterday titled Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (here), which (as its title suggests) fully outlines what the Agency does and does not consider wholesaling by an outsourcing facility. The examples of what a firm can and cannot do under the provisions of […]
The beautiful country of Malta was the backdrop of the 28th Annual Medicines for Europe Conference for 2023. One of the key themes of the conference was assuring a consistent supply of essential medicines to all of Europe. This topic was at the heart of all the sessions. Pharmaceutical manufacturing in Europe has a rich […]
Did Timothy Leary have it right? There is more interest these days in research into the use of psychedelic drugs as a therapy for many conditions and the FDA is getting on board by publishing a guidance document entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (here). The guidance notes that the “U.S. […]
Today, the Association for Accessible Medicines released a White Paper (here) that provides their views of the factors that may cause drug shortages and also provides some reasoned solutions to reduce and help prevent future drug shortages. While the white paper does indicate that the number of shortages has decreased somewhat over the past few […]
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 […]
