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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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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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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06
Feb
Information for the mass

More Info from the AAM Annual Meeting Regulatory and Policy Meeting

During her session yesterday at the AAM Annual Meeting, Iilun Murphy, M.D. provided additional details on the 2023 OGD metrics, indicating that there were 950 ANDAs approved and tentatively approved (782 and 172 approvals, respectively).  Of the approvals, there were 90 first generics, along with 83 generics with Competitive Generic Therapy Designation, and 111 complex […]

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06
Feb
Paper clipboard with text POLICIES AND PROCEDURES.

CARES ACT – 2024 Update – Big News!

Since the implementation of the CARES Act reporting requirement, the question continues to be asked: Is it really a requirement?  The answer is yes, and now it is no longer recommended, but is stated as “should” in the newly published Final version of the Guidance for Industry (GFI) “Reporting Amount of Listed Drugs and Biological […]

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05
Feb
Helpful Tips

AAM Annual Meeting Regulatory and Science Meeting

A presentation delivered by Office of Generic Drugs Director, Iilun Murphy, M.D. during the members-only Regulatory and Policy meeting at the start of AAM’s annual meeting provided seven tips for ANDA sponsors with regard to their ANDA submissions: Submit a clear cover letter. Describe what is being submitted. State whether the submission includes a labeling […]

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