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, […]
Almost two and a half months after the beginning of FY 2024, the first month of FY 2024 (October 2023) statistics appeared, almost like a Christmas present! And from the looks of the numbers, there is likely some coal in some of the statistical “stockings.” Let’s start with the Original ANDA approval numbers. The OGD did pretty […]
This has been a long time coming! Ever since the first approval of isotretinoin (Accutane – by Hoffmann La Roche, Inc. on May 7, 1982), and the associated safety requirements associated with that product’s labeling, the requirements for the safe use of isotretinoin products have become stricter. This type of safety information and requirements for […]
Yesterday, the FDA issued the first revision of the Guidance titled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (here). This Guidance covers the following four topics: Providing quantitative efficacy or risk information for the control group, when applicable; Presenting probability information in terms of absolute frequencies, percentages, and relative […]
An FDA notice contained in the Federal Register (FR) notice prepublication pages today (here) has put the final kibosh on the use of ciprofloxacin 100mg tablets due to current evidence demonstrating that the increased resistance of Escherichia coli (E. coli) to the low strength of ciprofloxacin makes it no longer effective for treatment of acute […]
Not sure what is taking the FDA so long to fix the system “glitch” in reporting ANDA approval actions, but this has been going on for quite a while. Here we are, the day before Thanksgiving, and there are only 14 full ANDA approval actions and 9 tentative approval actions listed in the available FDA […]
Bring up the recently updated and finalized EU Annex 1 – Manufacture of Sterile Medicinal Drug Products (here) in polite pharmaceutical water cooler conversation and a frequent topic that comes up is the Contamination Control Strategy (CCS) language. Buzzwords abound for a “holistic”, “global”, or “wholesale” CCS to be incorporated into all elements of aseptic […]
First, let’s look at September 2023 statistics (end of FY 2023), then we will comment on the full FY stats. As we reported here, September looked to be a slow month, and it was. While we missed a few full-approval actions (we reported forty-one), the OGD actually issued forty-four, and ten tentative-approval actions. Remember, the Agency […]
The EU has continued its advancement of initiatives and intentions to combat the drug shortage problem. The latest communication is titled “Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Addressing medicine shortages in the EU” (here). This is a deep dive […]
