Certify, Little viii, or Verification Must Now Be in Amendments for Certain Applications

For years, the debate as to when an amendment to an ANDA or a 505(b)(2) application had to include a new patent certification raged on, and, at times, was handled on a case-by-case situation if it was noticed at all. Even when I was at the Agency – when dinosaurs walked the face of the earth- there was disagreement among staff as the when such amendments required new patent certifications or little viii statement. 

USP, BP, EP, JP – Which Can You Cite In Your Application?

FDA published an updated Manual of Policy and Procedure (MaPP), 5310.7 after a 10-year first edition and this one (in my opinion) really clears up one of the age-old questions – can I cite a foreign compendia as the basis for establishing a specification or test method in my application?  The answer is a resounding YES!if the method is as good as or better than the USP/NF provisions in a Monograph or in the General Chapters.

No New Regulations – No New Hires – Will the Administration’s Actions Impact the Drug Approval Process?

Donald Trump signed an Executive Order freezing government hiring, except for the military, national security, or public safety personnel, and issued a memorandum placing a moratorium on any new regulations or Guidance. In addition, it is reported that the memorandum noted that if new regulations have been sent to the Federal Register, but yet unpublished,

FDA 2017 List of 101 Guidances – How Many Apply to Compounding Pharmacies and Are You Current and in Compliance???

For 503A and 503B compounding pharmacies, how do you protect your business from heavy-handed interventions from State and Federal Regulators? Can you affirmatively respond to the following questions?

  • Do you know the Federal and State laws you are required to follow?
  • Do you have the right enabling documentation (procedures, policies,

FDA Declares Drug Product Removed for Safety Reasons

Acthar Gel Synthetic (seractide acetate) injection, 80 units/mL and 40 units/mL, was the subject of NDA 017861, approved for Armour Pharmaceuticals on February 21, 1978, but was never marketed by the company.  A Federal Register notice (here) announces the FDA’s determination that the product, that was ultimately withdrawn in 2014, due to failure to submit an Annual Report,

Fish is Good for You, But Apparently, Not Too Much!

While we usually cover drug- and device-related topics in this blog, something came swimming our way on an unrelated topic that I thought might pique your interest.  I always thought that eating fish over red meat was a healthy choice.  Well, that is still true, as long as you don’t eat too much.  In a Federal Register (FR) notice (here) issued today,

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.