The Lachman Blog

Subscribe to our blog

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 […]

Read More
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 […]

Read More
21
Feb

Join Lachman Consultants (Ireland) at the PDA Ireland Event: Contract Manufacturing – Achieving & Maintaining a Successful Partnership, Cork, 29th Feb.

The one-day event will explore how to achieve and maintain good relationships with your Contract Manufacturer Organisation (CMO) Partners. Key industry leaders will share their perspectives on many topics such as the selection of a service provider, regulatory trends, and how to foster collaborative synergies when outsourcing. Lachman Consultants (Ireland) provides a full range of […]

Read More
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Today, the FDA published a draft guidance document titled Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance (here) regarding the annual registration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 […]

Read More
20
Feb
FDA Goes Back to Basics with Multiple Observations for Diethylene Glycol and Ethylene Glycol - Lachman Blog

FDA Goes Back to Basics with Multiple Observations for Diethylene Glycol and Ethylene Glycol

In 2022, there were six Warning Letters and five 483 observations for issues relating to Diethylene Glycol (DEG) and Ethylene Glycol (EG). In 2023, there were thirty-six Warning Letters and nineteen 483 observations for DEG and EG concerns. So far this year (mid-February 2024), there have already been three Warning Letters containing observations for DEG […]

Read More
16
Feb
Do You Know Your Product’s Impurity Profile - Lachman Blog

Do You Know Your Product’s Impurity Profile?

ICH Q7 refers to the need to establish the impurity profile for an Active Pharmaceutical Ingredient (API): “An impurity profile describing the identified and unidentified impurities present in a typical batch produced by a specific controlled production process should normally be established for each API. The impurity profile should include the identity or some qualitative […]

Read More
15
Feb

OGD Provides Update to Future Product Specific Guidances as Well as Planned Revisions 

Today, the FDA published a list titled Upcoming Product-Specific Guidances for Generic Drug Product Development, which can be found here and has two sections:  Planned New PSGs for Complex and Non-Complex Generic Drug Products (Updated February 15, 2024)  Planned Revised PSGs for Complex and Non-Complex Generic Drug Products (Updated February 15, 2024)  Section 1 contains a list […]

Read More
1 2 210