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 […]
Generally, pharmaceutical manufacturing involves laboratory testing on product sampled at the end of the manufacturing process to assure the product quality as part of the product release. However, traditional release testing is not the only acceptable approach used to assure the quality product prior to release. On September 15, 2015, the European Commission published a […]
On 11/11/15, at the ISPE Annual Meeting in Philadelphia, Russ Wesdyk from the FDA Office of Surveillance spoke about quality metrics. Since the FDA Metrics Guidance is still in draft and the comment period is still open, he didn’t provide any specifics about the Guidance itself. Since its issuance, industry has been studying and commenting […]
Dr. John Peters, the newly appointed Deputy Director of OGD, just posted a piece on the FDA website on the “Importance of the Physical Characteristics of Generic Drugs”. Dr. Peters also noted that OGD has taken a particular interest in what he termed “Patient-Focused equivalence” or something that I have termed “functionality” when I have been questioned about whether the concept of generic drug “sameness” had taken on new definitions.
