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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27
Dec
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 This revised draft, of the same name, outlines most of what was covered in the October draft guidance; however, it does include some clarifications and some additional information.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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12
Oct
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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27
Jul
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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06
Jun

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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15
Dec

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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03
Nov

Industry and Regulators Working to Prevent Drug Shortages

I recently attended the ISPE Annual Meeting, held October 29 through November 2, 2022 in Orlando, Florida.  The conference had varied content in areas such as Digital Transformation, Manufacturing Trends, Regulatory and Quality, Supply Chain Optimization, and Therapy Innovations.  The conference was well attended by both industry and regulators. Although I found all of the […]

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03
Nov

Convergence and Collaboration Themes at 2022 ISPE Annual

At the first highly attended ISPE Annual meeting since the pandemic hit, the themes that kept emerging from both sessions and attendees was convergence and collaboration. This concept reached its peak at the sessions that ended this conference, with a keynote from Peter Marks, MD/PhD, Director, CBER, FDA, the Regulatory Town Hall featuring representation from […]

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25
Oct

ARE YOU BEHIND?

The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices conference was held in Palm Springs, CA, October 18-19, 2022.   In attendance were some of the world’s largest providers in this combination space which included innovators, pharmaceutical companies, suppliers of injectable devices and contracted service providers.  The conference speakers presented on a variety of topics […]

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