A Fee that can Choke a Horse – But worth it!

FDA announced the fees for the Rare Pediatric Disease Priority Voucher and the Tropical Disease Priority Review Voucher in the Federal Register (here)  and (here).  These vouchers can be used to obtain priority review for another NDA or biologic application (BLA), or the vouchers can be sold to another sponsor to use as they see fit. 

First it Was Natural and Now it is Healthy – Your Comments, Please

After receiving thousands of comments on what the term “natural” should mean with regards to foods (see previous post here), the FDA is now reexamining the term “healthy” in food labeling.  In addition, they also released an immediately effective guidance to describe their thoughts on their proposed enforcement discretion relative to the use of the term.

Window into GDUFA II Outlined in Federal Register Notice

Well the negotiations for GDUFA II are completed, but what is in the works?  This morning a Federal Register Notice (FR) published announcing a public meeting on GDUFA II, but the notice itself provides some insight to the changes coming in GDUFA II and some big changes are coming.  The FDA plans to release its GDUFA II commitment letter (the bible of GDUFA) that will provide additional details on the program changes prior to the public meeting on October 21,

Self-Identification Guidance for Generic Facilities Issued by FDA

Under the Generic Drug User Fee Amendments (GDUFA) of 2012, all generic facilities, sites and organizations are required to comply with the self-identification requirements of the GDUFA.  This Guidance document is intended to facilitate firms’ understanding of the requirements, and thus, make self-identification easier to accomplish.  The document also discusses which of the facilities, sites,

Women in Pharma Debuts at 2016 ISPE Annual Meeting & Expo

ISPE presented the first in a series of planned annual events entitled, “The Women in Pharma” on Monday 19 September at its 2016 Annual Meeting. Key female pharmaceutical industry executives shared their stories at the morning session, focusing on the challenges and opportunities each embraced as they progressed though their careers.

The session was led by Charlotte Enghave Fruergaard,

Perhaps Thinking of Someone’s Similar Name? New MaPP May help Avoid Disappointment

Often times proposed proprietary names go down to the approval wire, and sometimes there is last minute disappointment on behalf of at least one of the sponsors.  For instance, when a proprietary name is cleared during the IND, NDA, or ANDA review, in the period between clearance and approval, there may be another applicant that gets approved with a look-alike or similar name that may,

Naloxone App Competition to Net Winner $40,000

The FDA is holding a competition to develop an easy-to-use application that will connect overdose victims with carriers of naloxone in an effort to help a rapid, and hopefully, successful overdose treatment with the drug.  This appears to be a different and unique kind of outreach program to help stem the tide of overdose deaths in what we now call the overdose epidemic. 

Data Governance – Establishing a Path Forward to Assure Data Integrity

Data integrity issues have cost pharmaceutical and healthcare companies millions of dollars in direct and indirect costs and led to potential risks to patient safety.  Companies are in a frenzy responding to regulatory citations and preparing for inspections.  The industry, mostly from “lessons learned”, generally understands the issues; and the regulatory expectations have been communicated through a number of recent guidances (drafts,

August FY 2016 ANDA Numbers Out for Receipts and Approvals

OGD fully approved (AP) 51 ANDAs in August and tentatively approved (TA) 14 applications for a total of 65 approval actions for the month.  Receipts of new original ANDAs was at 59 for the month, off of the monthly average of 72 (but remember, there were two big months that heightened that average).

Straight line full FY estimates for approvals are now at 653 (up significantly from FY 2015 approvals of 492,

Court Reverses Itself on NCE Issue-What Happens to ANDAs Already Received?

In a stunning reversal of opinion on the issue of FDA’s failure to award new chemical entity (NCE) exclusivity to the drug Prepopik, the world of NCE awards and ANDA acceptance for receipt for fixed dose combination (FDC) products that contain a first-time approved active ingredient may be turned on its head.  This was discussed in Kurt Karst’s excellent post on the FDA Law Blog (here) that details the legal issues of the case,

FDA Updates List of Guidance Documents It Plans to Issue in 2016

The FDA announced some additions (**) and revisions to titles (*) of Guidance documents it plans to release in 2016.  We have posted on this list previously (here) (and here) and highlighted this blogger’s impression of some of those proposed Guidance documents.  Well, FDA has published another revised list and here are the changes:

  • Comparative Analyses of the Device Constituent of a Drug-Device Combination Product Submitted in an ANDA ** –

ANDA Suitability Petitions Continue to Linger

As I dutifully read through this week’s Petitions and comments and Notices on regulations.gov, I came across a letter (here) telling FDA that the petitioner has responded to FDA requests and now the petition in over two years old and the petitioner wants FDA to expedite the review of its petition for an oral solution version of Trazadone.

Follow-up on New Final Rule for Drug Listing and Establishment Registration

After slogging through the 200+ pages of the Final Rule, here is a partial list of some of the comments I found interesting or that explain some of the changes or comments along with a summary of the FDA response from the Final Rule (here).

Comment 9 – Clarification of importers requirement to identify every entity it delivers product to will be narrowed in scope to the “importer”

19 Consumer Antiseptic Wash Ingredients Found Not to Be GRAS/GRAE

The FDA published a Federal Register (FR) notice today declaring that 19 ingredients for use in consumer antiseptic wash (use with water to wash off) are not generally recognized as safe and effective (GRAS/GRAE).  The Agency has however deferred a decision on three additional ingredients (benzalkonium chloride, benzethonium chloride, and chloroxylenol) for this use as additional studies and data are being reviewed at this time to support an Agency finding.