Simplifying the Complex Generics

During the afternoon session at the first annual GRx+Biosims Meeting held in Baltimore, MD, from September 5-7, 2018, a panel discussion was held to deliberate over aspects that are important to consider when developing a complex generic drug product. The panel consisted of FDA as well as generic industry representatives. GDUFA II provides drug manufacturers with several tools to assist in the development of complex generic drug products including enhanced communication opportunities with FDA and opportunities for innovative approaches in developing a complex generic drug.

The “Answer Key” for Inspection Site Selections

In a posting on FDA.gov yesterday, September 5, 2018, FDA Commission Scott Gottlieb, M.D., further reinforced his goals of an open and transparent FDA by publishing FDA’s internal policy on inspection site selections (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619435.htm).

The Center for Drug Evaluation and Research (CDER)  issued their internal policy Manual of Policies and Procedures (MAPP) 5014.1,

DI Still a Major Problem – but What’s Being Done About it?

The Association of Accessible Medicines (AAM) meeting in Baltimore this week saw a number of FDA presentations.  One that caught my attention was presented by Sarah Barkow, Ph.D., Acting Director, Manufacturing Quality Guidance and Policy Staff, Office of Manufacturing Quality in CDER.  It had to do with data integrity.

Dr. Barkow noted, “about 40% of OMQ’s warning letters include data integrity lapses.  

Facility Issues Sink Minor Amendment Designation

Historically, the Office of Generic Drugs (OGD) has classified major/minor amendments on the time necessary for review.  Minor amendments required minimal review, while major amendments required extensive review.  If there was an issue with a facility (e.g., cGMP), the old Deficiency Letters (DLs) and Complete Response Letters (CRLs) used to state that the firm should not respond to the letter until the facility issues have been resolved. 

OGD Updates July 2018 Statistics

As we know July was a record breaking month for approvals as reported here, but it was also a record shattering month for Complete Response Letters, beating the October 2017 previous total of 325 with a whopping 357 CRLs.  This may be a little disturbing as the trend in FY 2018 is for an overall increase in CRLs. 

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,