Compliance

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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21
Dec

CP Spurs FDA Decision that Alcohol in Dextrose was Withdrawn for Reason of Safety or Efficacy

In a move not often seen, a Citizen Petition was submitted asking the FDA to make a determination that certain Alcohol and Dextrose injection products were not withdrawn for safety or efficacy (S&E) reasons; In a Federal Register notice (here), the Agency took the opposing view and stated that all Alcohol and Dextrose injection products […]

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09
Nov
Back view business woman raising hand for asking speaker for question and answer concept in meeting room for seminar

AAM GRx-Biosims Meeting – Day Two, Morning

For those of us on the West coast, it was an early wakeup this morning, but well worth it!  Here are some highlights from the GRx-Biosims conference morning sessions. Dr. Sally Choe, Director, Office of Generic Drugs (OGD), opened the morning with the OGD keynote address.  Dr. Choe outlined the OGD’s performance during the pandemic, indicating that […]

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09
Nov

AAM GRx-Biosims Day 1 – Afternoon, Part II

The other session that I was able to monitor was the Cares Act – Additional Reporting Requirements for Manufacturers. The purpose of the new reporting requirements is to proactively identify potential drug or API shortages so that the FDA can begin to act and perhaps institute a flexible regulation approach to mitigate the shortage.  The […]

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03
Nov
Angry old couple in quarrel

The 5% Compounding Rule is Coming to a Head

On November 2, 2021, FDA posted an update to the Memorandum of Understanding (MOU) Addressing Certain Distributions of Compounded Drugs (here).  FDA notes that it was sued by seven compounding pharmacies (503A compounders) in US District Court regarding the 5% limitation on the out of state distribution of compounded products by pharmacies in states that […]

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27
Aug
Question mark with speech bubble on blue background

What It Is May Not Be What It Is!

In a Federal Register notice (here) that will publish on Monday, August 30th, the FDA announced that it “is withdrawing approval of the abbreviated new drug application (ANDA) for solifenacin succinate tablets, 5 milligrams (mg) and 10 mg, held by Breckenridge Pharmaceutical, Inc.”  Breckenridge waived its opportunity for hearing on the proposed withdrawal. What makes this instance so […]

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10
Aug

Limited, Inordinate, and Extended Can Kicking?

On 8/6/2021, a Federal Register Notice (here) was issued announcing an extension of the period before FDA intends to begin enforcing the statutory 5 percent limit on out of state distribution of compounded human drug products. FDA is extending the period for states to decide whether to sign the final MOU, (“Memorandum of Understanding Addressing […]

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