On February 9, 2023, the FDA issued a revised guidance (here) on the compounding of Ibuprofen oral suspension products for outsourcing facilities. We previously posted about the original document (here) and discussed the basic factors that caused the Agency to issue the guidance without public comment to meet the needs of a drug shortage that […]
Just think about the number of EUAs granted for at-home COVID testing. Then think of the information that is not being captured because people aren’t reporting the outcomes of all those home-administered tests. Remember the days when the number of reports of positive cases were daily headlines? Now, no one knows—or maybe it’s that so many […]
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 […]
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 […]
If you’ve finished reading War and Peace, I have another thriller for you to sink your teeth into. The FY 2022 GDUFA Science and Research Report (here) provides 134 pages of interesting discussions on the OGD’s GDUFA research projects, the outcomes and benefits derived from the research initiatives as translated into Product Specific Guidances (PSGs) for […]
As Lester Holt says prior to the closing segment on NBC World News, “There’s good news tonight” – at least in terms of ANDA approval times. In its first quarterly report for FY 2023 all of the approval metrics are under 30 months for the first time that I can remember. (see chart below). This […]
As the FDA notes, “Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review under section 505(j)(11) of the Federal Food, Drug, and Cosmetic (FD&C) Act and certain ANDAs with a competitive generic therapy (CGT) designation under section 506H of the FD&C […]
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 […]
The Food, Drug, and Cosmetic Act of 1938 was precipitated by a disaster where over 100 people died, many of whom were children. In the early 1930s, a wonder drug called sulfanilamide was marketed for treatment of certain infections. The problem with the drug was that it was very bitter, and, because of this, children […]
Obviously, we have waited longer for the official monthly statistics in FY 2023 than in previous years. In addition, in prior years, OGD published the approval actions, receipt of new ANDAs and complete response letters prior to releasing the full set of statistics. However, it looks like there will be no early view of these […]
