With the first half of the month in the books and postings up through April 17, 2024, the OGD has issued thirty full-approval actions and seven tentative-approval actions. At this rate, it is possible that the OGD will hit or break sixty full-approval actions in April. This could be the first month that the OGD goes […]
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 […]
At the Association of Accessible Medicines (AAM) February 2024 Annual Meeting Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director of CDER, made another interesting point in her presentation yesterday, outlining the number of national drug shortages that the FDA reported per calendar year (reproduced at the link below) and indicating that the press has reported […]
This month we will pat ourselves on the back as we captured the correct number of approval and tentative approval actions in our calculation of the unofficial numbers in our post here. We were more patient when looking at the February data from the daily approval page (which must be pieced together because it only […]
As the saying goes, March came in like a lion but went out like a lamb. The OGD issued only 48 full-approval actions and 13 tentative-approval actions for a total of 61. The beginning days of the month looked relatively strong but that kind of petered out towards the end of the month. The 48 […]
Today, the FDA published a Product Specific Guidance (PSG) with recommendations for establishing bioequivalence of oxymetazoline hydrochloride ophthalmic solution (here). As we have all recognized through the publication of numerous other PGSs over the last five years, the Agency is moving to BE waivers to establish sameness of the product as well as meet the […]
The number of reserve samples required by current regulations has been a sore subject for both NDA and ANDA sponsors as well as testing facilities as the cost and storage requirements for the required reserve samples of both test and reference product was overly burdensome. Now, after twenty years of concern expressed by the industry, […]
Thus far, the Office of Generic Drugs (OGD) has issued a total of 32 full-approval actions and 7 tentative-approval actions for a total of 39 approval actions through March 21st. Unless there is considerable upward action on approvals through the end of the month, it is likely that March will be the lowest month for […]
One of the most commonly used methods of extracting guidance on various issues from the Office of Generic Drugs is the Controlled Correspondence (CC) process. While this process is often maligned because of the high bounce back rate due to minor formatting or technical issues, the process is one of the only ways to obtain […]
On March 7, 2024, the FDA adopted ICH Guideline Q14 Analytical Procedure Development, which became official on November 1, 2023. This guidance complements updated ICH Guideline Q2(R2) Validation of Analytical Procedures, which also became official on November 1, 2023 and was adopted by the FDA on March 6, 2024. The Q14 guidance (here) combines a science- and risk-based approach […]
