29
Nov

Where Have All the Official Stats Gone, Long Time Passing!

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, […]

Read More
29
Nov

Accelerated Approvals – Here Is One to Watch

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 […]

Read More
08
Nov

GDUFA III Raises Hopes for Surprise PSG Issuance or Revision

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 […]

Read More
03
Nov

Activities Report of the Generic Drugs Program – GDUFA II Quarterly Performance

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 […]

Read More
03
Nov

Industry and Regulators Working to Prevent Drug Shortages

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 […]

Read More
03
Nov

Convergence and Collaboration Themes at 2022 ISPE Annual

At the first highly attended ISPE Annual meeting since the pandemic hit, the themes that kept emerging from both sessions and attendees was convergence and collaboration. This concept reached its peak at the sessions that ended this conference, with a keynote from Peter Marks, MD/PhD, Director, CBER, FDA, the Regulatory Town Hall featuring representation from […]

Read More
17
Oct

With GDUFA III Comes Revision to Many Guidance Documents – No Exception for PAS

With the coming of GDUFA III, many guidance documents have been changed, and new guidances have been released to address new issues under GDUFA III.  We have published posts describing many of the changes and now the FDA has issued an updated guidance on prior approval supplements (PAS) (here). The above‑cited guidance replaces the October 2017 guidance of […]

Read More
12
Oct

Final FY 2022 OGD Figures for Approvals and Receipts

Well, with the final FY 2022 totals now in for some of the OGD’s most important metrics, let’s see how this fiscal year stacks up other GDUFA years.  But first, September saw sixty-eight full-approval actions of which nine were for first-time generics and only nine tentative-approval actions along with ninety-eight new ANDAs and 141 Complete […]

Read More
1 2 36