Are the wheels coming off the plan to import drugs from Canada, just days after FDA approved Florida’s import plan? It appears that Canada is not too happy and will take any action necessary to assure that importation of drugs by one of the biggest states in the United States will not disrupt the Canadian […]
To all our readers – We wish you a happy holiday season and a very happy, healthy, and prosperous New Year. The Lachman blog will be taking a break over the holiday, starting Friday (unless something extremely urgent occurs), and I hope that all of you will join me back in the New Year as […]
Thankfully, it looks like the FDA has been able to address its IT issues, although approvals are now appearing more than a few days after the approval letters are issued. This peek at the numbers is provided for approval information posted as of December 20th – which includes posted approvals through December 15th. As of that date, […]
The Office of Generic Drugs approved eighty-two first-time generic products in FY 2023 for fifty-two different products. For example, the OGD approved sixteen ANDAs on the same day for Lisdexamfetamine Dimesylate Capsules (the generic for Vyvanse) on August 25, 2023. Each of these is counted as a first approval because they were all approved on the same […]
This morning, the FDA published the OTC Monograph request Fee rates for FY 2024 in a pre-publication Federal Register notice (here); these rates cover fees for OTC monograph order requests (OMORs) for which there are Tier 1 and Tier 2 requests. The distinction for the two classifications of OMORs are a Tier 1 request (usually […]
The FDA issued a White Paper titled CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, designed as the next step in the evaluation of key quality assessments designed to identify a high level of commitment to quality management at a manufacturing firm. In the document, the FDA cautions that “Information […]
Many of our blog readers have likely encountered moving goal dates for their ANDAs since October 1, 2022 and the beginning of GDUFA III. The GDUFA III Commitment Letter, available here, included several new enhancements to the generic drug user fee program as each iteration of the program has continued to do. The changes made to promote transparency […]
The statistical report (here) provides full official statistics through the third quarter Fiscal Year (FY) 2023. There is some good news when looking at mean and median approval time that we will discuss later. But for now, let’s look at some of the more important FDA approval actions for June 2023. OGD approved 76 new […]
On the Federal Register (FR) prepublication page today, the FDA outlined the new fee schedule for generic drugs under the GDUFA program for FY 2024. Make sure you have a bottle of Maalox nearby before you read the rest of this blog as the increases, especially for the program fees, might cause you some agita. Generic […]
Reference standards are used ubiquitously within a Quality Control laboratory and are integral to many test procedures. A laboratory should have defined controls for the use, handling, inventory management, and characterization of these standards, as well as consulting the WHO’s Annex 3 for “General guidelines for the establishment, maintenance, and distribution of chemical reference substances,” which […]
