The FDA published a revised guidance issue today (here) that revises a December 2020 guidance on Controlled Correspondence (CC) by the Office of Generic Drugs. This December 2020 guidance is being updated to reflect the new provisions of GDUFA III and its commitment letter relative to the submission of CC. “This guidance provides information regarding the […]
Taking a look at the unofficial approval information on the FDA website through December 16th, we found only twenty‑five ANDAs receiving full‑approval actions and six receiving tentative‑approval actions. That is a total of (obviously) thirty‑one approval actions. Given that number, if the OGD could double its approval output by the end of the month, that would […]
Well, the new statistics started rolling off the assembly line last night and appear in a new report that combines the generics monthly statistical report and the Quarterly Report. The new name of the report, which we discussed in a blog post (here), is the Generic Drugs Program Monthly and Quarterly Activities Report. We will […]
The FDA has revised the guidance, originally issued in July 2022, titled Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe (here) to include additional information as required relative to the performance goals outlined in the commitment letter for GDUFA III. While there aren’t many changes in the revision, it is certainly […]
The FDA is usually pretty consistent with the timing of their publication of official OGD metrics, especially when it comes to the publication of the Generic Drugs Program Activities Report – Monthly Performance. The first month of official stats has not yet been available and it is almost December. I was curious about the delay, […]
It is always interesting to see how the Agency works when one action could trigger another action. In the Federal Register pre-publication page (here) this morning, the “Food and Drug Administration (FDA) [announced that it] is withdrawing approval of new drug application (NDA) 019832 for SULFAMYLON® (Mafenide Acetate, USP) Powder for 5% Topical Solution, held […]
GDUFA III Raises Hopes for Surprise PSG Issuance/Revision Explained at AAM’s GRx-Biosims Conference The product specific guidance (PSG) has been a big help to industry in outlining the requirements for establishing bioequivalence requirements for generic drug products. OGD has issued over 2000 PSGs since the practice began. While this has been a big boon to […]
October is the first month of the fiscal year 2023 and, while not necessarily a bellwether of things to come, it is certainly the starting point of GDUFA III. The unofficial tally looks good as OGD issued 58 full approval actions and 11 tentative approval action for a total of 69 total approval actions. While […]
As Lester Holt says at the introduction of the last show segment on NBC Nightly News – “There’s good news tonight”. The same might be said of the recently released GDUFA II Quarterly Performance Report (here). The figures for the fourth quarter have some really good news. First, the number of ANDA awaiting FDA action […]
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 […]
