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 […]
Since the retirement of CVM Guidance for Industry (GFI) #42 “Animal Drug Manufacturing Guidelines – Series of Four Guidelines,” which was withdrawn in October 2019, the animal health industry has been anticipating guidance from the CVM on these topics. The first of four anticipated guidance documents was issued on March 18, 2024 as a draft (here), and […]
The FDA has been working with the Pharmacy Compounding Advisory Committee (PCAC) since the year 2000 to develop a list of drug products that present demonstrable difficulties for compounding. Concerns relative to bioavailability, variations in batch-to-batch consistency, and dosage-form release characteristics that could present significant safety (or other) issues are outlined in and provide a […]
One of the most commonly used methods of extracting guidance on various issues from the Office of Generic Drugs is the Controlled Correspondence (CC) process. While this process is often maligned because of the high bounce back rate due to minor formatting or technical issues, the process is one of the only ways to obtain […]
Visit with Lachman Consultants at Booth 635 PDA Week is a must-attend event for professionals in the biopharmaceutical and pharmaceutical industries. This year’s event is taking place from Monday, March 25th to Wednesday, March 27th in Long Beach, CA. As a leading forum for knowledge-sharing and networking, this year’s event promises to deliver insights into […]
Benzoyl Peroxide is the active ingredient in many acne creams, ointments, gels, and combination semi-solid products for the treatment of acne. These products are sold either by prescription or over the counter. Valisure is the same testing lab that uncovered the nitrosamine impurities in Ranitidine products that developed over the expiration dating life of drug […]
The OGD’s approval actions for the month (at least those posted by March 5, 2024) are in line with the first four months of this fiscal year. There were 52 full approval actions and 11 tentative approval actions for a total of 63 approval actions. While we have not seen January’s official statistics yet, the […]
FDA published a conversation piece on narrow therapeutic index drugs entitled, “Setting and Implementing Standards for Narrow Therapeutic Index Drugs” (here ) to better inform health care professionals (HCP), patients, and other consumers regarding the use of and how the FDA treats narrow therapeutic index (NTI) drugs. Let’s look at what an NTI drug is […]
Is your firm preparing for the wave of AI regulations, laws, white papers, and regulatory guidances? As reported in a previous Lachman blog, EU Artificial Intelligence (AI) Act: Impact on Pharma and MedTech, laws are emerging, but can companies keep up with the pace? Last year, the EU did what the U.S. has not been […]
