01
Mar
AI Laws on the Move - Lachman Blog

AI Laws on the Move

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 […]

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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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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 […]

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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 […]

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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 […]

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13
Feb

OGD Publishes Its Official December FY2024 Statistical Report 

Well, the first full quarter of FY 2024 results are in (here) and, while hardly astonishing by current standards, there was some good news revealed regarding new ANDA submissions.  Also, in a later post, we will provide our first full fiscal year estimates of ANDAs approved and received.  The OGD officially issued 53 approval actions in […]

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12
Feb
Metal clean shelves in market. 3d rendering

The “Hows” of Drug Shortages 

If there was one theme that was pervasive throughout the discussions and presentations at the recent AAM Access 2024 meeting in Tampa, Florida, it was related to drug shortages.  The issue was touched upon by representatives from AAM, officials from the FDA, CEOs, Doug Long of IQVIA, and others as well.  With different individuals providing […]

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09
Feb

Doug Long Receives Lifetime Achievement Award at AAM Annual Meeting After Presentation

Doug Long has become a fixture at AAM meetings, providing invaluable data on the drug industry on behalf of his employer, IQVIA.  This presentation is always the highlight of AAM annual meetings.  All attendees at this meeting make sure to have their seats nice and early to hear his state of the generic and biosimilars […]

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