Today, the FDA issued twenty-six new and six revised Product Specific Guidances (PSGs) (here). PSGs provide the Agency’s current thinking on acceptable methods for demonstrating bioequivalence between the Reference Listed Drug or the Reference Standard designated by the Agency (if the RLD is no longer available) and the proposed generic product. These latest PSG additions […]
At the Center for Drug Evaluation & Research (CDER) Small Business Industry Assistance (SBIA) meeting held on April 25th, titled “Facilitating Generic Product Availability Through Product-Specific Guidances (PSGs) for 2024,” the FDA presented some updates regarding the FDA Dissolution Database. Dr. Leah Falade, Senior Pharmacologist in the Office of Pharmaceutical Quality, CDER, was the presenter in Session 6. […]
The FDA recently hosted a webinar focused on the facilitation of generic drug product development through Product Specific Guidances, also known as PSGs. The CDER Small Business & Industry Assistance (SBIA) held a webinar titled Facilitating Generic Product Availability Through Product-Specific Guidances (PSGS) for 2024 on April 25th. The slides and recordings will soon be posted […]
Well, we hit the nail on the head (at least for approval actions in March)! As predicted in our April 5th post (here), OGD issued 48 full approval actions and 13 tentative approval actions for a (low) total of 61 approval actions, and that is exactly what OGD is reporting in its official monthly stats […]
A review of recent Form 483s and Warning Letters shows that investigations continue to be a focus of FDA inspections, where the following citation is commonly issued: There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether […]
This morning, I was reading an article written by Sally Turner in Pharmaceutical Technology (here), suggesting that the FDA take a greater role in the review and validation of the patents that brand-name companies list in the Orange Book (OB). She addresses the Hatch-Waxman Act’s patent listing provisions and discusses other views held on the […]
Join us at this year’s conference for a great exchange of ideas, and the celebration of FDLI’s 75th Anniversary! Lachman Consultants is excited to be part of the upcoming 2024 Food and Drug Law Institute (FDLI) Annual Conference, scheduled for May 15-16 in Washington, DC. The conference serves as an invaluable platform for professionals across […]
Well, it must be true that April showers bring May flowers. A shower of approvals in April is something we haven’t seen in a while. The OGD unofficially issued sixty-eight full-approval actions and eleven tentative-approval actions for a total of seventy-nine for the month. We still must wait for the official numbers to be posted, […]
Container Closure Integrity (CCI) testing is a central aspect of contamination control for a product. Contamination control strategy begins with the design, qualification, and validation of a facility, equipment, and processes. Product containers and closures are a crucial element of contamination control. Package integrity is the ability of the package to prevent loss, maintain sterility, […]
FDA has finalized its long-awaited Final Rule on Medical Devices; Laboratory Developed Tests (here). This Rule has been percolating within the Agency for a while and is the final step since the Proposed Rule was issued October 3, 2023. FDA explains that since “1976, the Medical Device Amendments of 1976 (the MDA) amended the FD&C […]
