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 […]
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 […]
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 […]
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, […]
The Food and Drug Law Institute (FDLI) recently held its 2023 Annual Conference on May 17-18 in Washington, D.C. where professionals from the food, drug, medical device, biologics, and tobacco industries gathered to hear important updates and panel discussions from a distinguished group of industry and FDA speakers. The Conference commenced with keynote addresses by […]
In the generic drug business, most times it is best to be first! This means trying to be first in development, submission, and (of course) approval. But, in order to have a chance of being first, you must know what to do, and that is especially true of knowing what the bioequivalence (BE) requirements are. […]
Join Lachman Consultants (Ireland) in Leipzig, Germany for the 2023 Parenteral Drug Association (PDA) Good Aseptic Manufacturing Conference on May 23 – 24, to discuss the implications of the new GMP Annex 1 and share insights to help you prepare. As a Gold Sponsor at this year’s event, Lachman will be represented by: John Darby, […]
Join Lachman Consultants at this year’s FDLI Annual Conference in Washington, DC, May 17 –18, 2023, for a two-day hybrid event that will address complex legal, regulatory, compliance, and policy issues in all facets of the FDA-regulated industry. Lachman Consultants will be represented by: Martin Shimer (Executive Director) Rachel Thompson, JD (Senior Director) David Petshaft, […]
Coming off the March total of 117 (ninety‑six full approvals and twenty‑one tentative approvals), April’s numbers are good but fall short of any big records. April saw the OGD unofficially issue sixty‑four full‑approval actions and eleven tentative‑approval actions for a total of seventy‑five approval actions. If these figures hold firm when the official numbers are […]
