The 15 approvals for the generic of Cialis come on the day of the expirations of the 180-day exclusivity enjoyed by the first-to-file applicants. Assuring that the ANDAs gain approval on the first legally possible date that they can be approved means that the price will go down and, when 15 ANDAs receive approval, the […]
As many dietary supplement marketers are essentially virtual companies, all manufacturing and testing is performed by organizations contracted by the marketer. In the ten years or so since the dietary supplement GMPs went into effect, control of these contractors has been an ongoing challenge. Most dietary supplement marketers have demonstrated adequate control over their […]
This morning the FDA released a guidance document entitled Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling (here) which provides direction to firms that are developing labeling for pediatric patients based on findings of required or literature studies or data that are either positive, negative or inconclusive. The guidance goes on to […]
Coauthored by Kurt Karst (of FDA Law Blog) and Bob Pollock The “Petitioned ANDA”—It’s a route to ANDA approval that’s been around since even before the enactment of the 1984 Hatch-Waxman Amendments. For several years after the enactment of Hatch‑Waxman, the petitioned ANDA was a mainstay of the generic drug industry’s drug development paradigm. And although […]
Every day, when I look at the ANDA approvals list, I see that most of the approvals are for the older ANDAs that were submitted to OGD before Year 4 of GDUFA I (when goal dates started). Some of these applications are anywhere from six to ten years old. Once they receive approval, they have […]
(Westbury, NY – March 2019) On the heels of establishing a European based presence last year, Lachman Consultant Services, Inc., a leading provider of expert compliance, regulatory affairs, and technical services to life sciences organizations worldwide, will return to the ISPE Europe 2019 Annual Conference. Lachman is sponsoring the event on April 1-4, where they […]
We are pleased to announce that Amy Schutte has accepted the position of Senior Associate, Regulatory at Lachman Consultants, effective March 28, 2019. She will report to Aloka Srinivasan. Ms. Schutte is a pharmaceutical industry professional with specialization in Regulatory Affairs and experience in quality, regulatory compliance, and pharmacovigilance. After nearly 20 years in the […]
With numbers reported to date through March 15th, it looks like the OGD will reach ninety approval actions this month. There have been thirty-eight full approvals and seven tentative approvals reported so far this month. With the OGD averaging eighty-eight full approvals for the first five months of FY 2019, it will need to push […]
Over the last two days, the FDA has announced the recall of two products from two different companies (here and here), each due to the presence of particulate matter in the product. One was confirmed as glass particles and the other as a copper salt (particulates seen at the twelve-month stability station). This is reminiscent […]
The FDA’s posting of the approval for the “priority” review ANDA for Valsartan mentioned yesterday (here) occurred today. The ANDA number was listed as 205536. It is interesting to note that the ANDA number corresponds to an application that was submitted around the middle of 2013. That is almost six years! It is interesting to […]
