04
Apr
New Cephalosporin Class Antibiotic Approved by FDA for Three Uses - Lachman Blog

New Cephalosporin Class Antibiotic Approved by FDA for Three Uses

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 […]

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19
Mar
Displeased Woman Waving Her Finger Against A Pink Background

Demonstrably Difficult to Compound List Proposed Rule Issued by FDA – Will Compounders Balk?

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 […]

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12
Mar
supplement bottle Packaging

Guidance on Labeling Changes for Approved OTC NDAs/ANDAs Provides AR Reporting Examples

Today, the FDA published a guidance titled “Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products” (here) that provides advice on the types of changes to OTC NDA and ANDA product labeling that may be submitted in an annual report.  The guidance provides for “minor changes” that may be made but also […]

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07
Mar
Could Benzoyl Peroxide be the Next Nitrosamine Nightmare - Lachman Blog

Could Benzoyl Peroxide be the Next Nitrosamine Nightmare?

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 […]

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01
Mar
medical fraud

FDA Provides Advisory on Two More Dietary Supplements with Hidden Drug Ingredients

Yesterday, the FDA advised consumers not to use QUICK Rheumatism Capsule, Tiger Wang Biaod (here) or SNAKE BONES Anti-Rheumatic Capsules (here).  The FDA confirmed by its laboratory analysis that both products contain piroxicam, a prescription drug ingredient for treating pain and arthritis-related symptoms. Serious adverse events can occur with taking any of these unapproved drugs […]

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27
Feb
FDA Questions Safe Use of Smartwatches and Smart Rings to Measure Blood Glucose - Lachman Blog

FDA Questions Safe Use of Smartwatches and Smart Rings to Measure Blood Glucose

The Agency warns patients not to rely on glucose levels measured by the above devices unless they are reporting glucose-level data generated from an FDA-authorized device for measurement of blood glucose by a device that pierces the skin. The Agency says that readings from devices that do not puncture the skin may provide unreliable glucose […]

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