An Injection of Advice on Generic Drug-Device Combination Products from FDA

In another generic drug Guidance issued in the beginning of the year, OGD Guidance tsunami, FDA has provided advice on how to decide what might be necessary to gain approval of an ANDA, where there is a drug-device patient interface.  FDA notes throughout the Guidance that each ANDA will be evaluated on a case-by-case basis and the deciding factor will be that (as first explained in an old petition response to King Pharmaceuticals) “[i]n general,

Reference Listed Drug, Reference Standard, Basis of Submission – FDA Guidance Sheds New Light

On Friday, the FDA issued a draft Guidance entitled, “Referencing Approved Drug Products in ANDA Submissions” (here).  The document describes what a reference listed drug (RLD) is, what an FDA reference standard (RS) is (a relatively new term with important distinctions from the RLD), and describes how the selection process should occur if the RLD is no longer marketed or removed from sale,

180-Day Exclusivity Guidance – Oh, How Sweet It Is

Like looking for something in the junk drawer in your house, you know it’s in there, but you really must rummage around to find it.  The FDA issued its Guidance for Industry: 180-Day Exclusivity:  Questions and Answers earlier this week and it is the junk drawer of 180-day exclusivity.  It contains a compilation of questions and answers that bring together FDA’s decisions on 180-day exclusivity that may have come from court cases,

Good News/Not So Good News II? Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities

FDA issued the draft Guidance “Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities” (here) in late December 2016.

FDA reminds us that, under current law, radiopharmaceuticals that are compounded by entities that are not registered with FDA as outsourcing facilities (503B), and radiopharmaceuticals that are repackaged are subject to all applicable provisions for the production of drugs under the FD&C Act.

Breaking the ANDA Bank – December Submissions Off the Chart

In a previous blog, we postulated that the start of FY 2017 looked like the ANDA submission rate could be off to the races.  We also speculated that December original new submissions might reflect firms’ end of year push to get applications into the Agency.  We did not think we would see a submission number as high as the 235 reported by OGD for December 2016. 

Good News/Not So Good News? Compounding and Repackaging of Radiopharmaceuticals

FDA issued two new Guidance for Industry Documents late in 2016: (1) Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities (here) and (2) Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities (here).  These represent the 25th and 26th  draft and/or final Guidances issued by FDA relating to pharmacy compounding.  

FDA Issues Three New Guidances for Compounding Pharmacies on December 28, 2016

FDA issued three new Guidance for Industry Documents late in 2016: (1) Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act (here) ; (2) Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities (here); and (3) Compounding and Repackaging of Radiopharmaceuticals by Outsourcing facilities (here).

Botanical Drug Development Guidance Undergoes Its First Revision

First issued in draft in 2004 and then revised as a draft in 2015, Revision 1 of the Guidance document “Botanical Drug Development” issues in final form.

The Guidance reflects current Agency thinking on the drug development process for new drugs (NDAs), investigational new drug applications (INDs) to support NDAs, and a discussion of the appropriate mechanism for seeking inclusion of botanical products in the over-the-counter (OTC) monograph system.

November 2016 OGD Stats Updated

OGD posted additional statistics relative to metrics that it routinely tracks by month.  Included in these numbers are data on Refuse-to-Receive (RTR) actions, supplements received, controlled correspondence, etc.

All of FY 2016 monthly RTR actions were in the double digits except for September, which saw only 9 RTR actions.  Well, 2017 seems to be starting in the right direction as the October and November RTR actions were reported at 9 and 8. 

More Bioequivalence Guidance Documents Issued by OGD

The Office of Generic Drugs (OGD) has been busy in the bioequivalence arena as evidenced by its issuing of 31 new recommendations and revising 17 previously issued recommendations.  The list of new and revised recommendations can be found here.

As always, there are some specific recommendations that are of note while others are standard bioequivalence recommendations. 

Happy Holidays from All of Us at Lachman

I can’t believe another year has slipped away already. Seems like yesterday I was writing the holiday blog for 2015 and here we are again.  This year brought us the renegotiations of all of the UFAs, the largest number of Generic Drug approval since the new counting system went into effect (for those of you who don’t know what I am talking about – you are too young,

Revised RTR Guidance – Merry Christmas!

Today, FDA released a second revision to the ANDA Submissions – Refuse-to-Receive Standards, here,  a holiday present to all.  OGD noted that the RTR rate hovered between 10-14% over the last few years and a total of 379 ANDAs (not related to failure to pay required GDUFA fees) have been RTR-ed ANDAs during FY 2013 through FY 2015. 

Boxed Warning for Serious Mental Health Issues Removed from Chantix and Zyban Labeling

Back in April 2016, we posted a blog regarding the potential for the FDA to remove the Black Box warning on two products indicated to help patients stop smoking based on a large clinical study that the FDA required.  At that time when the studies were submitted, the Agency indicated it would review the results and make a final determination. 

FDA Publishes List of First Bulk Drug Substances for 503A Compounding

The FDA issued a Proposed Rule (here) that announced the first additional 6 bulk drug substances for inclusion on the listing of bulk drug substances acceptable for pharmacy compounding, although they are neither the subject of an applicable United States Pharmacopoeia (USP), nor National Formulary (NF) monograph, nor components of FDA-approved drugs.