It’s not the big things that you need to worry about; it’s the little things that will kill you! And nothing is truer than that when it comes to microbial bugs that have become resistant to antibiotic therapy! The rise in “Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the […]
A review of Warning Letters issued in 2023 and 2024 (to date) by the U.S. FDA to manufacturers of drug products and cosmetics shows the presence of some findings that are seen more frequently than others. One of these is the following: “Your firm failed to test samples of each component for conformity with all […]
For the last several years, there has been a push in the industry to take a systematic approach and design quality into your systems and processes by establishing up front requirements such as QTPP for process validation and ATP for analytical methods. Such an approach provides invaluable benefits to the public whereby, the manufacturer has […]
Today, the FDA published a Product Specific Guidance (PSG) with recommendations for establishing bioequivalence of oxymetazoline hydrochloride ophthalmic solution (here). As we have all recognized through the publication of numerous other PGSs over the last five years, the Agency is moving to BE waivers to establish sameness of the product as well as meet the […]
Section 744M of the FD&C Act (21 U.S.C. 379j-72), authorizes the FDA to assess and collect: (1) facility fees from qualifying owners of OTC monograph drug facilities and (2) fees from submitters of qualifying OTC Monograph order requests(OMORs). OMOR fee rates for Fiscal Year (FY) 2024 were published on September 12, 2023 (see blog post […]
In a press release issued yesterday (here), the FDA warned six companies about topical lidocaine products that can cause serious health effects and are also unapproved new drugs. The products are recommended for use after certain dermatological procedures “such as microdermabrasion, laser hair removal, tattooing and piercing.” These products are being marketed at concentrations above […]
You’re invited to visit with Lachman at Booth #47. We hope to see you at the 10th Anniversary American Biomanufacturing Summit, one of the can’t-miss events of the year. It’s taking place on April 10-11, 2024, at the Hyatt Regency San Francisco Airport, San Francisco, CA. The American Biomanufacturing Summit is one of the most senior-level […]
The number of reserve samples required by current regulations has been a sore subject for both NDA and ANDA sponsors as well as testing facilities as the cost and storage requirements for the required reserve samples of both test and reference product was overly burdensome. Now, after twenty years of concern expressed by the industry, […]
Thus far, the Office of Generic Drugs (OGD) has issued a total of 32 full-approval actions and 7 tentative-approval actions for a total of 39 approval actions through March 21st. Unless there is considerable upward action on approvals through the end of the month, it is likely that March will be the lowest month for […]
Do you struggle with modern data backup methods on industrial automation? Sometimes these “islands of automation” are not conducive to well-established methods when there is no apparent network connection. In cases such as these, a frequent choice is to use a flash drive. This technology is available in most Human Machine Interfaces (HMIs) and Programmable […]
