More on the Final Rule on ANDAs and 505(b)(2) Applications Image

Final Rule on IVDs Issued, Along with Two Guidance Documents 

FDA has finalized its long-awaited Final Rule on Medical Devices; Laboratory Developed Tests (here).  This Rule has been percolating within the Agency for a while and is the final step since the Proposed Rule was issued October 3, 2023.  FDA explains that since  “1976, the Medical Device Amendments of 1976 (the MDA) amended the FD&C […]

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FDA Continues Execution of HHS AI Strategy - Lachman Blog

FDA Continues Execution of HHS AI Strategy

The U.S. Department of Health and Human Services’ (DHHS) strategy for artificial intelligence (AI) is clearly continuing in earnest into 2024. This AI strategy states, “HHS divisions will continue to lead in identifying opportunities for mission-driven AI solutions, mitigating risks appropriately, against a shared framework of federal and HHS guidance.” In alignment with this strategy, […]

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FDA Publishes Medical Devices Quality System Regulation Amendments Final Rule 

The 101-page Federal Register (FR) document published on the prepublication page of the FR today (here) describes the rule in detail and provides responses to comments received by stakeholders on the proposed final rule.  The FDA states:  “We are amending part 820, primarily to incorporate by reference ISO 13485, Medical Devices—Quality Management System Requirements for Regulatory Purposes.  […]

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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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The Eyes Have it - Lachman Consultants Blog

The Eyes Have it!

On December 27, 2023, the FDA released a revised draft version of its October 2023 guidance titled Quality Considerations for Topical Ophthalmic Drug Products: Guidance for Industry. This revised draft, of the same name, outlines most of what was covered in the October draft guidance; however, it does include some clarifications and some additional information. The […]

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Close-up medical syringe with a vaccine.

Drug-Device Combinations for Generic Drugs: A Good Session at AAM’s GRx+Biosims Conference

Remember the good old days, when a dosing spoon or cup was dispensed with liquid medication and a product in a prefilled syringe was just a drug?  Well, we know now that those days are over, and maybe they should be.  The presentation by three FDAers, Markham Luke, MD, PhD, Karyn L. Berry, MD, MPH, and […]

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Woman worried about bills

BsUFA and MDUFA FY 2024 Fees Published! Good News for BsUFA Fees, Not So Much for MDUFA Fees

The schedules for the 2024 Biosimilar User Fees (BsUFA) (here) and Medical Device User Fees (MDUFA) (here) have been posted on the Federal Register prepublication page and are scheduled for final publication on August 28, 2024.  BsUFA Fees  The Biosimilar User Fee Amendments of 2022 (BsUFA III) authorize the FDA to assess and collect user fees for […]

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Collectively Shaping the Future of Healthcare at the MedTech Forum 2023 in Dublin Ireland

Recognized as a global center for education, arts and culture, administration, and industry, Dublin Ireland was a beautiful and fitting backdrop for the MedTech Forum 2023, where Europe’s medical technology community congregated to collaborate on the future of the industry in a city well-known for its long history of shaping the future. MedTech Forum 2023 […]

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Devices to Head onto the Inspection Delay or Refusal Bandwagon

Since July 9, 2012, the day that the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public 19 Law 112-144) was signed into law, drug products are deemed “adulterated for which a manufacturer processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or […]

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