While I rarely use others’ comments in full to populate this blog, I think that Ralph Neas, President and CEO of GPhA, said all that needs to be said on the state of GDUFA and the hope for future improvements – so here is.
On March 26, 2015, we blogged about an April 20-21 FDA Public Hearing regarding examining the need for the drug enforcement policy surrounding homeopathic drugs. Since the conclusion of that hearing, just under 3500 comments have been received from FDA.
Today is June 11, 2015, and there are major milestones being hit. First of all, today is my 44th wedding anniversary – that’s a big one! But also, by the end of the day, the Office of Generic Drugs (OGD) will have close to 30
Just a quick note about yesterday’s posted figures, OGD updated the figures as follows:
In a Federal Register notice today (here), FDA announced its finding that Ondansetron Hydrochloride Injection USP, in plastic, ready-to-use containers containing 32mg/50mL was removed from the market and withdrawn for safety reasons.
In a series of FDA Safety Alerts, Recall Notices, and Enforcement Actions over the last couple of years, the Agency has notified consumers of dozens of OTC products that contain undeclared and dangerous drugs.
The Office of Generic Drugs (OGD) had another good (OK) month in terms of approval actions with the approval of 44 ANDAs and tentative approval of 13 for a total of 57 approval actions for the month…..
The Office of Generic Drugs (OGD) had another good (OK) month in terms of approval actions with the approval of 44 ANDAs and tentative approval of 13 for a total of 57 approval actions for the month. The number of receipts totaled 40 – obviously just under the number of full approvals for the month.
Industry does not always get either the filing type or the need to file the change correct and, sometimes, due to an overabundance of caution, makes supplemental submissions when they may be able to either report the changes in an Annual Report or may not need to report the change at all, but manage it under their Pharmaceutical Quality System (PQS).
Industry has been dealing with deciding which post-approval changes need to be reported to FDA, based on a series of Guidance documents (i.e., SUPAC-IR, the three Changes to Approved Application documents, CMC Post-Approval Changes to be Documented in Annual Reports) and, of course, the regulations at 21 CFR 314.70 and 601.12. Industry does not always get either the filing type or the need to file the change correct and,
Since my post yesterday, a number of readers pointed out that the DMF assessment requirement as a basis for Refuse-to-Receive file determination has been removed from the previous guidance. I concur that is the case, and there are and may be multiple reasons for its removal.
The newly revised Refuse-to-Receive (RTR) Guidance for ANDAs was issued on May 26, 2015 and was published on the FDA website the same day.
There are certain products that must be Q1 (qualitatively) and Q2 (quantitatively) the same, in terms of active and inactive ingredients, in order to avoid having to conduct in vivo pharmacokinetic or bioequivalence studies with clinical endpoints.
The FDA posted its activity associated with the some unregistered wholesalers that target doctors’ offices and clinics offering discount drugs. In addition, FDA has sent letters to doctors and clinics that may have purchased counterfeit or unapproved drugs.
With June 15th quickly approaching, the industry is preparing to discuss the progress under GDUFA I with FDA while also being able to extol the successes and shortcomings of the first iteration of GDUFA.