FDA released a presentation by John Jenkins, M.D., Director, Office of New Drugs at CDER. The report is rather astounding and signals that the PDUFA program and the way FDA approached drug approval is not only collaborative but also thorough. One rather amazing piece of information is the first action approval rates for FY 2015. […]
The FDA approved Vistogard (uridine triacetate) as an emergency treatment for patient having severe toxic reactions or receiving an unintentional overdose of either fluorouracil or capecitabine. The treatment is a breakthrough for these patients and can be a life saver and/or permit earlier reintroduction of necessary chemotherapy.
We have read a lot about the significant rising cost of some generic drug products, some shortage products, and some old products without competition, even though any period of patent or exclusivity has expired. The entire issue of pricing appears to be focused on a handful of drug products. We certainly don’t want to see the system keep patients from getting the drugs they desperately need and we don’t want to break the bank of private pay patients, insurers, and local, state, and federal governments. So there needs to be a balance. How do we achieve that balance?
The news is that the FDA is postponing its decision on its Proposed Labeling Rule until July 2016. Mark that month on your calendar because it will mark the time where either FDA adopts a modified position or the legal process will likely be initiated by many in the generic industry.
As we previously reported (here), OGD approved 61 ANDAs and Tentatively Approved 6 ANDAs in November; thus there was appositive reduction of 24 applications in the theoretical backlog. This is (somewhat) the good news and the bad news. The good news is that OGD should have substantive excess review resources available, based on a reduced number of applications received. The bad news is-you are going to pay more for fewer applications.
We have reported on discrepancies in the reporting of the number of approvals on the FDA Monthly Approvals Report (here and here) in various posts (here and here) . In addition, we have reported on the problems that FDA staff has had with the implementation of their new IT platform (here, here, and here) […]
November was a good month for full approvals, with a total of 61 issued. There were 6 tentative approvals issued for the month. While this is a bit of a fall off from the previous few months, the numbers are consistent with an even keel on approvals. The hopeful goal for now is to […]
FDA approved the first genetically engineered fish which they have determined is safe for our food supply. The fish is engineered to grow faster, which will, of course, make it a more abundant food source. Who knew a fish could be approved through a new animal drug application (NADA)? Not me!
The Office of Generic Drugs (OGD) would like the generic industry to know that it is poised to bring home the bacon on approvals. The industry has the table set, but, according to some, the meal has yet to be served. This “trust, but verify” position comes at a time when the GDUFA II […]
The FDA announced the approval of Narcan (naloxone hydrochloride) Nasal Spray as an alternative emergency treatment for accidental opioid drug overdose. Previously, naloxone hydrochloride, which reverses the effects of opioids very rapidly, was available only as an injection available in a syringe or auto-injector. In a press release issued today (here), FDA notes that, because […]
