26
Jan

OGD Finalizes Good ANDA Practices Guidance

Originally published on January 4, 2018, the Agency says it has finalized and revised the guidance document in response to “comments received on the draft guidance as the guidance was finalized and made minor edits and other editorial changes to improve clarity. Revisions include clarification of the recommendations pertaining to patent and exclusivity deficiencies, as […]

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25
Jan
Blackboard Business Strategy Concept

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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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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23
Dec

IPledge Isotretinoin REMS Prompts FDA Flexibility and Plea to Manufacturers

The IPledge Risk Evaluation and Mitigation (REMS) program was designed to address the significant potential for serious birth defects should a pregnancy occur during treatment with the drug isotretinoin which is used to treat acne. The program covers both males and females, since isotretinoin can be passed through the semen of males if the male […]

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CP Spurs FDA Decision that Alcohol in Dextrose was Withdrawn for Reason of Safety or Efficacy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