Sometime today, according to a pre-publication in the Federal Register, the FDA will post twenty-six new bioequivalence guidance documents and announce the revision of seventeen more. Since February 2018, the FDA has issued sixty-one new guidances and revised forty. The OGD has indeed been busy but while the industry loves to see the new guidances, […]
In my 44 years in the industry, I don’t think any issue has raised as many questions, caused companies to scratch their heads or raised the level of angst more than the issue of the dreaded Field Alert Report (FAR). Well now – and finally – the FDA has issued a Q&A document that answers […]
When an NDA holder lists a patent in the Orange Book (OB), it sometimes appears that the patent listing use claim, or other information is challenged by prospective ANDA applicants. FDA has updated its Listing of Patent Disputes (here) through July 13, 2018. This is the first time that we have seen this list (maybe […]
FDA approves two types of drug products –Prescription (Rx), and Over-The-Counter (OTC). Well, they also approve other types, i.e., Biologics etc., but for the purposes of this Blog post, it is the Rx and OTC that are applicable. Prescription drugs require the intervention of a health care provider, and are typically for products where the […]
Very seldom do we see a notice of recall that relates to a change in the manufacture or processing of the Active Pharmaceutical Ingredient (API), but that is what appears to have happened in this instance. The FDA announcement states: The U.S. Food and Drug Administration is alerting health care professionals and patients of a […]
“Part 111 (21 CFR part 111) establishes the minimum Current Good Manufacturing Practice (CGMP) necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement.” 21 CFR 111.75(a)(1) of these regulations provides a process whereby a dietary supplement manufacturer can petition the Agency for an exemption […]
This goes in the “where did this come from?” category. In an earlier post on July 5th where we looked at the available data on the FDA daily approvals and All approvals page for the end of June 2018, we only came up with 67 full and 6 tentative approvals (TAs) actions (see post here). […]
OGD updated its monthly Activities Report Of the Generic Drug Program FY 2018 for certain statistics that had not yet been posted (here). While we wait for the June 2018 official approval and receipt figures, let’s have a look at some of the interesting May statistics. OGD reported 8 refuse-to receive (RTR) actions, with an […]
As far as the available numbers for ANDA approvals and tentative approvals goes, for June, it appears we will have in the neighborhood of 67 full approvals and 6 tentative approvals for the month, more or less in line with what we have seen in the past few months. These numbers were derived from the […]
Today, as a 4th of July present, and in anticipation of celebratory fireworks, the FDA has issued a final guidance entitled ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA (here). The final guidance explains that the complex tiered amendment classification system of GDUFA I was abandoned to provide a less cumbersome and […]
