In a recent speech given to the 2016 Opioid and Drug Abuse Summit, FDA Commissioner Dr. Robert Califf outlined the FDA’s plans on addressing the opioid abuse epidemic and touched on a number of important and critical issues that underscore the tough job ahead of them. He emphasized that there needs to be a multipronged […]
Just when you thought it was safe to go back into the ocean, someone spots another shark. As noted in our post yesterday (here), the Office of Generic Drugs (OGD) fully approved 63 ANDAs and tentatively approved 16 ANDAs in March. We were hoping to see approval actions outpace receipts, however, much to our surprise, […]
FDA had the second highest monthly post-GDUFA number of full ANDA approvals at 63, and with 16 tentative approvals the total for approval actions for March 2016 hits 79. The full ANDA approval picture is looking a bit rosier with the second highest month this FY and also the second highest number of full approvals […]
About a week ago I began getting calls and getting feedback about a change in the Office of Generic Drugs (OGD) Approval letter format. What might appear at first to be a minor change has raised the eyebrows of many in industry and represents yet another “transparency” faux pas that occurred without warning or without explanation.
The key to developing a practical approach to all phases lies in the establishment of Critical Quality Attributes (CQA) for the drug product and assignment and monitoring of Critical Process Parameters (CPP) that have a direct effect on the performance of the process with regard to the CQA. At the PDA Annual Meeting last week, Scott Bazzone, Senior Manager of Quality Assurance Validation at Pfizer presented the approach that is used there with regards to establishing the risk significance or Z Score of a CPP to the CQA.
The questions about what and how a generic abuse-deterrent product has become somewhat more clear with the issuance today of the Draft Guidance for Industry – General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products. The Guidance document describes the types of tests (comparative in vitro studies and, in some cases, relevant pharmacokinetic or other studies that may be appropriate) that a generic applicant should undertake when seeking approval for a Reference Listed Drug (RLD) opioid product that has abuse-deterrent properties described in its labeling.
The Office of Generic Drugs (OGD) has updated its organization chart, but trying to figure out who is who in most of the OGD Office and Divisions remains a bit mysterious. Try to find the titles and position of many of the OGD staff and you kind of run into an electronic wall. Even if you know their names, their position and location within OGD, they are not easily discernible.
On Monday we posted about an issue that was brought to our attention relative to OGD’s position on goal date assignment, or lack thereof, to an ANDA with unresolved eCTD problems. We provided examples of some of the issues that firms were finding and we found that while there is merit to asking firms to […]
The generic drug industry complained about the GDUFA Goals Letter in the past, when it thought it had negotiated more than goals for Complete Response Letters (CRLs) rather than clear movement towards application approval. Well, some three years into GDUFA I, there now seems to be a better understanding of what industry thought they got and FDA has adopted, albeit outside of the direct language in the Goals Letter, policies that are driving application towards approval.
Life is always a picnic and deciding what to bring is sometimes a chore. The key is to assure there are no ants! Well, the generic industry has waited to hear what would be brought to the prioritization picnic and now the third revision of the MaPP 5240.3 lays out the meal. The entire MaPP should be reviewed and studied carefully so you best understand the FDA position on priority and expedited review.
