The development of antibody-drug conjugates (ADCs) typically involves using monoclonal antibodies (mAbs) “linked” to a cytotoxic drug and used as a specific targeting mechanism to deliver highly potent drugs to a surface antigen present only on tumor cells. Think of it as the biologics version of a smart bomb, with a targeting system able to […]
If I told you that over 50% of the new novel drugs approved in 2023 are used to treat rare conditions, would you believe me? Well, you should as the chart below shows that 51% (28 of 55) of the novel drugs approved by the Center for Drug Evaluation and Research (CDER) last year were […]
We have written extensively about the attack on the section viii label carve-out that is permitted under the Hatch-Waxman Act (H-W); this carve-out allows certain changes to a generic drug’s labeling to avoid patent infringement or certain exclusivity protection (here, here, here, here, and here). This so-called section viii label carve-out was part of the delicate balance […]
The FDA keeps track of first generic drug approvals for each calendar year and just posted the number for the first six months of calendar year 2024 here. Be aware that the OGD also posts first approvals in its Generic Drugs Program Monthly and Quarterly Activities Report (here) but the first approvals posted on this […]
Visit with Lachman Consultants at Booth #314 during the event. We hope you’ll be joining us at the annual PAD/FDA Joint Regulatory Conference on September 9th-11th at The Westin Washington, DC Downtown. This years can not miss event is entitled Current Good Manufacturing Practice (CGMP): Leading with Quality and Integrity,” and will provide in-depth knowledge […]
About eleven years ago, when I was dropping my son off at school before going to work, I was taking a sip from my coffee mug. From the back seat, my son shouted, “Daddy, don’t drink and drive!” I was surprised – did he learn that in school? He had started kindergarten barely a month […]
The official numbers for June 2024 are in and posted on the FDA’s website here. The OGD issued fifty final full approvals along with fifteen tentative approvals in June. Of the fifty approvals, four were first time generic approvals and nine (18%) were first-cycle approvals. Of the fifteen tentative approvals, there were no first-cycle approvals. […]
Based on a Federal Register (FR) notice issued in December 2023 (here), the FDA has determined that ciprofloxacin 100 mg tablets taken in a three-day regimen to treat uncomplicated urinary tract infections are ineffective based on resistance developed over time to E. coli, the primary causative agent for uncomplicated UTIs (see previous post here). Since that time, […]
It seems that the pace of approvals in July 2024 slowed and, as a result, our mid-month estimate of possibly hitting 90 approvals was dashed by a late-month drop in approval actions. The OGD did, however, unofficially issue 63 full-approval actions and 12 tentative-approval actions for a total of 75. (As a reminder, at mid-month, the OGD had […]
While the fees for outsourcing facilities all went up this year, at least the increases in these fees won’t break the bank (at least not yet). These fees represent the inspection fees associated with outsourcing facilities (better known as compounding facilities) under section 503B of the Federal Food, Drug, and Cosmetic Act. They are designed […]
