As we know, many drug products are approved initially only for adult patients. The Pediatric Research Equity Act (PREA) of 2003 “gives FDA the authority to require pediatric studies in certain drugs and biological products. Studies must use appropriate formulations for each age group. The goal of the studies is to obtain pediatric labeling for […]
Another bit of good news for generic approvals! June unofficially recorded seventy‑five full‑approval actions and thirteen tentative‑approval actions for a total of eighty‑eight approval actions for the month. The seventy‑five full approvals represent the second highest number of full‑approval actions in a month thus far this FY, with the big daddy still being March with […]
The FDA has just revised its MaPP 5014.1 titled Understanding CDER’s Risk‑Based Site Selection Model. Remember, MaPP stands for Manual of Policy and Procedures, and MaPPs instruct internal FDA staff on proper procedures. The FDA publishes these MaPPs to provide greater transparency to stakeholders so they can better understand how the Agency does something or […]
Well, we’re just four months from the end of FY 2023 and the approval numbers still stand strong. In May, the OGD issued sixty‑three full‑approval actions and eighteen tentative‑approval actions for a total of eighty‑one approval actions. Of the sixty‑three full‑approval actions, six were first‑time generic approvals and thirteen (20.6%) were approved in the first cycle. […]
Well, June got off to a rousing start! In the first fifteen days, the OGD issued forty‑six full‑approval actions and nine tentative‑approval actions. This represents one of the best mid‑month totals (fifty‑five) that we’ve seen in a long time. If the month continues at this pace, we’re likely to see over 100 approval actions for […]
A day or so ago, the FDA released Manual of Policy and Procedure (MaPP) 5021.5 titled Assessment of Facility‑Based Deficiency Major‑to‑Minor Reclassification Requests. A MaPP is a document that informs how the FDA will handle, manage, and prosecute a particular issue internally. In this case, it describes how the FDA will adjudicate a request to […]
How do you stop a drug shortage? Make it profitable for more than one, two, or even ten generic companies to sell the drug. History has shown that when five (5) or more players enter a generic field, the drug price drops substantially. Have more than 5-7 players – the price drops to 80% of […]
A few days ago, the FDA published a guidance document titled Cover Letter Attachments for Controlled Correspondence and ANDA Submissions (see here) that describes three checklist attachments for various types of ANDAs and related submissions. The checklists are identified as being voluntary, but the OGD suggests that not only can they aid applicants in ensuring […]
Many of our clients and readers have NDAs, ANDAs, and supplements that are still pending approval due to a “complex regulatory issue” where the FDA has missed its goal date; in some cases, this missed date was many months ago. There can be several reasons for this type of delay but, as we have blogged […]
Prescription Medication Information (PMI) will, if FDA has its way, replacing medication guides and other information provided to patients. The goal of the new PMI is to “highlight essential information that the patient needs to know about the prescription drug product and basic directions on how to use the product. The pre-publication of the proposed […]
