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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06
Oct

Most User Fees for FY 2023 Appear on Federal Register Pre-Publication Page Today – But a Glitch with GDUFA Fees?

The schedules for the 2023 Prescription Drug User Fees (PDUFA) (here), Biosimilar User Fees (BSUFA) (here), and Medical Device User Fees (MDUFA) (here) have been posted and are scheduled for final publication on October 7, 2022.  However, the Generic Drug User fees (GDUFA) FR Notice has a stark word “WITHDRAWN” on the prepublication page with the […]

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17
Aug

Now Hear This!

With the long-awaited FDA final rule on OTC hearing aids entitled Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids is now on the books, the Agency has issued a final guidance (here) on these products which explains the differences between, and the new regulatory framework for both hearing aids and personal sound […]

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22
Dec

Medical Devices Guidances on Transition Plans After Termination of EUAs Issued by FDA

The FDA’s Center for Devices and Radiological Health issued two guidance documents to address the transition plans for device EUAs issued during the COVID-19 public health emergency (PHE).  The first guidance is titled Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and the companion […]

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09
Aug

Have an Approved NDA or ANDA for a Contrast Agent or Other Similar Device? Better Read This!

In a Federal Register Notice scheduled to publish on Monday August 9, 2021 (see prepublication notice here), FDA indicates “[O]n April 16, 2021, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision in Genus Med. Techs., LLC v. FDA, 2021 U.S. App. Lexis 10928 (April 16, 2021). The U.S. Government […]

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