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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22
Feb
Mid-Month Peek at Unofficial OGD Approvals for February 2024 - Lachman Blog

Mid-Month Peek at Unofficial OGD Approvals for February 2024

Based on approvals posted through February 16, 2024, the OGD has issued 28 full-approval actions and 5 tentative-approval actions so far in the month of February. Given that February is a short month to start with and has one federal holiday, we may get additional help as it’s a leap year and the additional day may […]

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21
Feb
Medical Device Guidance on Small Business Waivers of Annual Establishment Registration Fee - Lachman Blog

Medical Device Guidance on Small Business Waivers of Annual Establishment Registration Fee

Today, the FDA published a draft guidance document titled Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance (here) regarding the annual registration fee. When this draft is finalized, it will supplement the Medical Device User Fee Small Business Qualification and Certification Guidance and address the waiver provisions of the […]

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