PDUFA Fees for FY 2019 Announced

A Federal Register Notice (here) released today announced the new Prescription Drug User Fees (PDUFA fees) for FY 2019.  And while there had been a modest increase, the fact is the there is an increase signifies that there is little expectation that fees will retreat anytime in the next few years. 

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Biosimilar User Fees Announced for FY 2019

The Federal Register notice published today (here) announces the FY 2019 biosimilar user fees.

The initial Biologic Product Development (BPD) fee is due when the sponsor submits an Investigational New Drug (IND) application to the Agency or within five days after the FDA grants the first BPD meeting.  The annual BPD fee is assessed the following FY and each year until the sponsor submits a marketing application or until the sponsor notifies the FDA that it is no longer participating in the program;

26 New Bio Guidance and 17 Guidance Revisions since March 27, 2018

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,

FAR from Reality – Q&A Document Provides Answers to Age Old Questions

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 many of those head- scratching questions.

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FDA Updates Patent Listing Disputes

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 we were asleep at the switch),

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More OTC Products Coming to a Shelf Near You?

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 patient cannot self-diagnose the condition for which the product is intended. 

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Valsartan API impurity Leads to Recall of Some Products

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 voluntary recall of several drug products containing the active ingredient valsartan,

Petition to Request an Exemption from 100‑Percent Identity Testing of Dietary Ingredients

“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 for 100% identity testing for dietary ingredients. 

OGD Updates May 2018 Statistics

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,

Preview of June 2018 Approvals

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 FDA All Approvals list (here) and the FDA Approved Drug Products list of daily approvals (here).