There is a hint that the “pause” or freeze on communications from the FDA may be starting to thaw. This morning, a CDER Small Business and Industry Assistance (SBIA) Webinar titled Navigating Controlled Correspondences to Support Generic Drug Development, to be held on February 27, 2025 from 1:00 to 3:30 p.m., was posted with a request […]
The OGD posted 29 new and 31 revised product-specific guidances (PSGs) today (see here). The new list of PSGs covers drugs with various dosage forms including tablets, capsules, gels, oral suspensions, intramuscular extended-release suspensions, topical solutions, powders, ointments, other parenteral products and orally disintegrating tablets, and subcutaneous extended-release suspensions. One of the new PGSs for […]
A pre-publication Federal Register notice today (here) announced the first group of product-specific guidances (PSGs) for which the requirement for a fed, in-vivo bioequivalence (BE) study has been removed. In some instances, the fasting, in vivo bioequivalence requirements were modified such that now only one in vivo study will be required to support a bioequivalence […]
On September 20, 2024, we posted a blog on the changes that are being contemplated by the FDA with issuance of the final M13A guidance (here). One of the major changes delineated in this guidance was elimination of the previous requirements for fed bioequivalence studies in over 850 different Product Specific Guidances (PSGs) for solid oral […]
Today, the FDA released a final guidance titled Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA (here). Wading through the 26-page document is a bit of a chore, but there is a lot of useful information that will provide applicants with advice on what to do, when to do it, and how to […]
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 […]
What is the answer to the question? Apparently, at the FDA’s Center for Drug Evaluation and Research (CDER) Small Business Industry Assistance (SBIA) Generic Drug Forum for 2024 (held April 10-11), it was Controlled Correspondence (CC). The FDA conducted two presentations exclusively on CCs and responded with that answer on more questions than not throughout […]
First, please be aware that many of the numbers you may have seen reported in our blog posts for various OGD actions were reported for Fiscal Year 2023, which ran from October 1, 2022 through September 30, 2023. The Office of Generic Drugs 2023 Annual Report (here) is a bit different as it reports OGD actions from […]
