Regulatory Affairs

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Today, the FDA published a draft guidance document titled Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance (here) regarding the annual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

AAM Annual Meeting: CDER Discusses Biologics and CEOs React 

At the recent AAM meeting, Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, CDER, provided an overview of the current state of activities at the Agency regarding biosimilar development and approvals.  The FDA has been quite successful in implementing its biosimilar program and has moved the needle on approvals.  Here are some of the points […]

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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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07
Feb
Worried African American man student holding papers in hands, bad exam results, refusal of admission

The Generic Industry Faces External Challenges

At yesterday’s AAM annual meeting, David Gaugh, AAM’s interim President and CEO, discussed the unprecedented events that threaten the sustainability of today’s generic drug and biosimilar industry.  In his keynote address, he addressed how the generic drug and biosimilar industry is being stressed by economic issues, PBMs, government programs, and other events out of its […]

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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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