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. 

Wooden Blocks with the text: Fees

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;

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).  

Amendments, business and law concept. Folder Register on desk

Final Guidance on ANDA and Supplement Amendments Hits the Newsstands

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 more straightforward classification of amendment types,

Outsourcing and Compounding Pharmacies Under FDA Scrutiny for Topical Pain Products, But That’s Not All

FDA Commissioner Scott Gottlieb issued a statement (here) on the Agency’s continuing position related to compounded drugs for patients that cannot use an FDA approved product.  However, the bent taken in his statement leans more towards the issues of safety and efficacy, while he points to the Department of Justice’s (DOJ) recent healthcare fraud enforcement actions related to the use of multi-component compounded products thought to artificially increase billing rates for these compounded products.

Goal Solution Concept on Blackboard

GDUFA II Regulatory Science initiative – AAM Provides Good Advice

On June 25, 2018, the Association of Accessible Medicines (AAM) submitted comments to Docket FDA-2017-N-6644: Generic Drug User Fee Amendments Reauthorization of 2017; Regulatory Science Initiatives; Public Workshop and provided some very interesting and relevant comments and suggestions.  The full text of the AAM comments can be found here, but here is a peek into the basket of suggestions.