Go Fund Me Page Contemplated for Headstone at Grave Site of 505(j)(2)(C) Petitions

I just searched through 643 hits on Regulations.gov for 505(j)(2)(C) petitions.  Granted, all of those were not actually for ANDA suitability petitions under the citation listed above, but most were.  The good news is that the industry still submits these petitions (an ANDA suitability petition requests a change from a reference listed drug in strength,

BsUFA and GDUFA – Time to Pay

The Food and Drug Administration announced yesterday that the Biosimilar User Fee (BsUFA) program invoices for Fiscal Year (FY) 2019 were emailed to sponsors on August 27, 2018.  Sponsors should expect to receive their invoices by August 29, 2018.  This follows the PDUFA FY 2019 PDUFA program fee invoices which were emailed on August 15,

Nominations to FDA Bulk Drug List for 503B Compounders Provides Three Strikes

In yesterday’s Federal Register (FR) prepublication page, the FDA described three drugs that were nominated for inclusion on the bulk list but all three were declined for the same basic reason.

Inclusion on the bulk list would have provided 503B-registered compounding facilities with the ability to utilize the substances in bulk in order to prepare finished-drug compounded product directly from the active pharmaceutical ingredient. 

Halfway Through the Month for Generic Approvals and Where Are We?

July was an amazing month for generic drug approvals with a total of 126 (ninety-six full approvals and thirty tentative approvals).  We were wondering whether such a figure would be sustainable or whether it might empty the “ready-to-approve” bucket at OGD.  We know the effort it takes to pump out that many applications and refill the pipeline and get those approval packages lined up for the next month. 

FDA Determines That Danocrine Is OK, But Not for All Indications

The FDA responds to numerous petitions each year asking for determinations as to whether products that have been withdrawn or discontinued from marketing have been so removed for safety or efficacy reasons.  Such determination is necessary to permit the continued marketing of other approved ANDAs that cite a Reference Listed Drug (RLD) as their basis for submission,

Chew on This!

Today, the FDA finalized a draft guidance that issued on June 16, 2016 titled Quality Attribute Considerations for Chewable Tablets (here).  The document provides advice to sponsors of NDAs, ANDAs, some chemistry supplements, INDs, and manufacturers of non-application chewable products on the critical attributes that should be identified and quantified for chewable immediate release tablets.

Training Materials related to ICH Q11 Questions & Answers – Selection and Justification of Starting Materials; The Saga Continues

In August 2018, the ICH Q11 Implementation Working Group (IWG) published training material in the form of a PowerPoint presentation for better clarification of ICH Q11 Questions & Answers – Selection & Justification of Starting Materials.  The presentation can be found here: Q11 IWG – slide deck training material (choose “read only” option to view) .  

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.