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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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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17
Dec

December Mid-Month Generic Approval Actions Look a Bit Anemic

FDA approval actions listed through December 15th include only seventeen full‑approval actions and six tentative‑approval actions for a total of twenty‑three total approval actions.  As it stands, if these numbers represent one half of a month, it would mean that, at the current pace, we would see forty‑six total approval actions for the month of […]

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13
Dec

Another Additional Workload Issue That Will Actually Help FDA and Industry

On December 10, 2021, the FDA issued a guidance titled Cover Letter Attachments for Controlled Correspondences and ANDA Submissions, which can be found here.  The guidance suggests that ANDA applicants can help their own causes by utilizing a checklist as an attachment to the cover letters of ANDA submissions and controlled correspondences submitted to the […]

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10
Dec

Three More Residual Solvents and PDEs Cited in Q3C(R8)

Today, the FDA published the eighth revision of a guidance titled Part VI: Impurities: Residual Solvents (Maintenance): PDES For 2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tertiary-Butyl Alcohol (here).  This revision adds the three residual solvents named above and provides permitted safe daily exposure (PDE) limits for patients. The guidance provides information on the solvents themselves, the […]

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09
Dec

FDA Finalizes Guidance on Annual Reportable CMC Changes for Specified Biologic Products

In today’s Federal Register (here), the FDA announced the availability of a final guidance for chemistry manufacturing and control changes (CMC) that may be reported in an annual report (AR).  CMC changes that may be submitted in an annual report are considered minor changes.  The FDA says, “This final guidance updates the draft guidance of […]

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