Regulatory Affairs

25
Jan
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Peek at the January 2022 Approval Actions

With ANDA reporting through January 21, 2022, the OGD has issued thirty full‑approval actions and eight tentative‑approval actions for a total of thirty‑eight approval actions issued so far this month.  With only six more reporting days remaining, these unofficial numbers, gathered from the FDA All Approvals list here, it looks like the total approval actions […]

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18
Jan

Official December 2022 ANDA Approvals, CRLs, and Receipts Hit the Web

We hit the number of December full‑approval actions on the head (thirty‑four) in our post here; however, we were way short on our estimate of tentative‑approval actions.  We noted thirteen at the time of publication in the above‑listed article but the official total reported this morning was twenty‑two.  Thus, the total number of approval actions […]

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12
Jan

Saving the Skinny Label: Could Another Case Bring It Off the Respirator?

This morning, Sara W. Koblitz of Hyman, Phelps & McNamara posted a blog titled “Is The Skinny Label Back From the Dead?” (here) that suggests there may be hope for the skinny label after all.  The blog details the GSK v. Teva decision and the potential dire implications for the skinny label.  She also outlines […]

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05
Jan

A Peek at December 2021 Approval Actions – Was There a Holiday Slowdown?

December of FY 2021 sure didn’t break any records as the OGD managed to eke out only 34 full‑approval actions and 13 tentative‑approval actions.  We would have to go all the way back to February 2018 to find a lower full‑approvals total for a month, and the total for that month was 32.  The tentative‑approval […]

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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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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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