Join Lachman Consultants at Access!™ AAM Annual Meeting 2023

Visit with Lachman Consultants in Griffin Foyer, Booth #4 at the AAM Annual Meeting. Lachman Consultants is a proud Business Exposition Sponsor of this yearly event that’s taking place at the JW Marriott Orlando Bonnet Creek Resort & Spa in Orlando Florida on February 13th-15th, 2023.  Access!™ is where policymakers, influential speakers and industry leaders […]

Read More

January 2023 Unofficial Approval Actions and an Explanation!

As we have noted in previous posts, the OGD has two types of approval actions for the various categories of approvals and tentative approvals.  What the heck does that mean?  Well, let’s take an example from this month’s approval actions.  On January 24, 2023, the OGD approved one fentanyl application; however, that single application had […]

Read More

Mid-January Peek at ANDA Approval Actions

With just about half of the month gone, and given that there have already been two holidays in January, the reported number of full-approval and tentative-approval actions looks pretty promising.  Through January 17th at 9 a.m. Eastern time, the OGD has listed twenty-eight full-approval actions and ten tentative-approval actions in the All Approvals database for a total […]

Read More

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
1 2 12