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Today, the FDA published a draft guidance document titled Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance (here) regarding the annual registration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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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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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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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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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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25
Jan
The Court Case That Could Have Implications Beyond Its Borders - Lachman Blog

The Court Case That Could Have Implications Beyond Its Borders

This morning, when I read a Decision and Order issued by the United States Court of Federal Claims regarding a motion that was granted in part, denied in part, and filed on behalf of a pharmaceutical company and the FDA, the hair on the back of my neck stood on end. Now, I must state […]

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19
Jan
January 2024 Mid-Month OGD Approval Actions - Lachman Blog

January 2024 Mid-Month OGD Approval Actions

Well, after a somewhat underwhelming start to FY 2024 (which began in October 2023), as reported here, it looks like things are picking up on the approval front for ANDAs. With approval postings through January 17th available today, the OGD has issued thirty-two full-approval actions and ten tentative-approval actions. This should bode well for a better January […]

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