Generics

16
Feb

Final Day at AAM Annual Meeting – “CEOs Unplugged” Highlights

The most popular program of each year’s AAM Annual Meeting is always the CEO unplugged session.  Oftentimes there are significant disagreements between the different CEOs regarding strategy, but this year there was almost complete agreement on strategic issues, policy, the marketplace, and regulatory issues.  The four panelists were Sven Dethlefs, Ph.D, Executive Vice President, North […]

Read More
15
Feb
Key Points

Some Highlight Facts from the AAM Annual Meeting on Tuesday – Oh, and, By the Way, Robert Califf was Confirmed as FDA Commissioner Today!

(Not that we had anything to do with Califf’s confirmation but we are all glad that this is in the Agency’s rearview mirror and it now has a permanent rudder for the foreseeable future.) Anyway, the AAM annual meeting is in full swing and I thought that I would give a few bullet points of […]

Read More
07
Feb

The Unofficial January 2022 OGD Approval Actions Tally

January 2022 was a much better month than the previous, thanks to (what looked like) an end‑of‑the‑month approval flurry as twenty‑seven ANDAs received full‑approval actions in the last five business days.  Remember that these are unofficial totals gathered from the FDA’s Recent New and Generic Drug Approvals list (here) and the Agency’s All Approvals List […]

Read More
01
Feb

CARES Act Manufacturing Quantities Reporting Requirement – Better Sharpen Your Pencils!

Back in November 2021, the Lachman blog brought your attention to the changes coming with the new FDA reporting requirements that were instituted under the March 2020 CARES Act (section 3112(e)) when it was reported at the AAM GRx-Biosims conference.  This new law, enacted for COVID‑19 response and relief, includes “enhanced” abilities for the FDA […]

Read More
28
Jan

O-O-O-Ozempic, A Hit with ANDA Submitters

Ozempic (semaglutide) is advertised on TV quite a bit.  The jingle (identified in the title to this post) kind of sticks in your head.  Ozempic is approved “for adults with type 2 diabetes used along with diet and exercise to improve blood sugar and lower A1C.  It also lowers the risk of major cardiovascular (CV) events […]

Read More
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4, 2018, the Agency says it has finalized and revised the guidance document in response to “comments received on the draft guidance as the guidance was finalized and made minor edits and other editorial changes to improve clarity.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 […]

Read More
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 […]

Read More
1 28 29 30 131