Complex Generics Get a Shot in the Arm (Leg Actually!) with First Generic Epinephrine Auto-injector Approval

The FDA announced today (here) the first approval of a generic equivalent to Epi-Pen, the combination product used to treat severe allergic reactions.  The FDA’s announcement acknowledges that approval of “complex” generics, like some combination (drug/device) products, can be very challenging.

The FDA has always said that for most complex drug device products,

NDA and BLA Resubmission Review Timelines Outlined in Revised MaPP

The FDA published its second revision of “Classifying Resubmissions of Original NDAs, BLAs, and Efficacy Supplements in Response to Complete Response Letters,” MaPP 6020.4 today.

The FDA issues MaPPs to provide instruction to its internal staff on policy and procedure in dealing with various issues.  The document identifies resubmissions to NDAs, BLAs, and efficacy supplements as either Class 1 or Class 2 submissions. 

Biosimilars and Complex Generics Uptake Not as Expected – Why is that a Surprise?

Many articles had decried the fact that biosimilar uptake is not what FDA or the drug industry anticipated.  Look, I have been around in this industry in one form or another (pharmacist, regulator, and consultant) for 46 years and have seen a lot in my day.  They say history repeats itself – no I am not planning to go back to FDA – but the same concepts and forces are in play today as they were when Hatch-Waxman (H-W) was first passed. 

OMG! OGD Shatters ANDA Approval Actions for July – and More!

While we reported that July had already broken the previous approval record prior to the official July numbers being posted in an earlier post (here) we were happily shocked when the official approval numbers came out today (here).  OGD fully approved a record 96 ANDAs (previous record was 88 in June FY 2017) and tentatively approved 30 ANDAs (previous record was 23 in November 2017 (also in FY 2018) for a total 126 approval actions!

Avoid Another Elemental Impurity Meltdown – Read the Final Guidance

After a disastrous start to the new year and the significant slowdown in approvals resulting from the OGD’s strict application of the provisions of the USP Elemental Impurity Chapter while awaiting harmonization with ICH Q3D, the approvals have begun flowing again.  There are some changes in the final guidance (here) from the draft that the FDA made in the harmonization effort. 

Ready Set Go! NDC Number Change Needed in Next Ten to Fifteen years

The National Drug Code (NDC) number is a unique identifier for prescription drug products.  The format, as explained by the FDA below, will need to be changed in the coming years to accommodate the entry of new labelers into the U.S. market.  The advanced Federal Register Notice published today (here) outlines the issues and announces a public hearing on the topic.

Welcome to the 21st Century – FDA Goes Greener!

On May 30, 2018, Diana Amador, Program Division Director, Office of Pharmaceutical Quality Operations (OPQO), Division I, issued a letter to “Our Regulated Pharmaceutical Industry”.

This letter offers firms an opportunity to submit all FDA 483 responses in electronic format up to 100 megabytes. If files exceed 100 megabytes, they may be submitted as smaller files in additional emails.

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. 

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;